Untitled

European Journal of Heart Failure (2011) 13, 1028–1040doi:10.1093/eurjhf/hfr039 Which components of heart failure programmesare effective? A systematic review and meta-analysis of the outcomes of structured telephonesupport or telemonitoring as the primarycomponent of chronic heart failure managementin 8323 patients: Abridged Cochrane Review† Sally C. Inglis 1, Robyn A. Clark 2, Finlay A. McAlister 3, Simon Stewart 1,and John G.F. Cleland 4* 1Preventative Health, Baker IDI Heart and Diabetes Institute and Faculty of Nursing, Midwifery and Health, University of Technology, Sydney, Australia; 2School of Nursing andMidwifery, Queensland University of Technology, Queensland, Australia; 3Division of General Internal Medicine, University of Alberta, Edmonton, Canada; and 4Academic Unit ofCardiology, Castle Hill Hospital, East Yorkshire, UK Received 28 October 2010; accepted 9 November 2010; online publish-ahead-of-print 6 July 2011 Telemonitoring (TM) and structured telephone support (STS) have the potential to deliver specialized management tomore patients with chronic heart failure (CHF), but their efficacy is still to be proven. The aim of this meta-analysis was toreview randomized controlled trials (RCTs) of TM or STS for all-cause mortality and all-cause and CHF-related hospi-talizations in patients with CHF, as a non-invasive remote model of a specialized disease-management intervention.
We searched all relevant electronic databases and search engines, hand-searched bibliographies of relevant studies, sys- tematic reviews, and meeting abstracts. Two reviewers independently extracted all data. Randomized controlled trialscomparing TM or STS to usual care in patients with CHF were included. Studies that included intensified managementwith additional home or clinic-visits were excluded. Primary outcomes (mortality and hospitalizations) were analysed;secondary outcomes (cost, length of stay, and quality of life) were tabulated. Thirty RCTs of STS and TM were identified(25 peer-reviewed publications (n ¼ 8323) and five abstracts (n ¼ 1482)). Of the 25 peer-reviewed studies, 11 evaluatedTM (2710 participants), 16 evaluated STS (5613 participants) with two testing both STS and TM in separate interventionarms compared with usual care. Telemonitoring reduced all-cause mortality {risk ratio (RR) 0.66 [95% confidence inter-val (CI) 0.54 – 0.81], P , 0.0001 }and STS showed a similar, but non-significant trend [RR 0.88 (95% CI 0.76– 1.01),P ¼ 0.08]. Both TM [RR 0.79 (95% CI 0.67 – 0.94), P ¼ 0.008], and STS [RR 0.77 (95% CI 0.68 – 0.87), P , 0.0001]reduced CHF-related hospitalizations. Both interventions improved quality of life, reduced costs, and were acceptableto patients. Improvements in prescribing, patient-knowledge and self-care, and functional class were observed.
Telemonitoring and STS both appear effective interventions to improve outcomes in patients with CHF. SystematicReview Number: Cochrane Database of Systematic Reviews. 2008:Issue 3. Art. No.: CD007228. DOI: 10.1002/14651858.CD007228.
† This paper is based on a Cochrane review first published in The Cochrane Database of Systematic Reviews (CDSR) 2010, Issue 8 (see www.thecochranelibrary.com for infor-mation). Cochrane reviews are regularly updated as new evidence emerges and in response to feedback, and the CDSR should be consulted for the most recent version ofthe review.
* Corresponding author. Tel: +44 1482 461776, Fax: +44 1482 461779, Email: [email protected] on behalf of the European Society of Cardiology. All rights reserved. & 2011 Cochrane collaboration, reproduced with permission. For permissions please email:[email protected].
Outcomes of STS or TM as the primary component of CHF management Systematic review † Meta-analysis † Telemonitoring † Heart failure Structured telephone support (STS) is monitoring and/or self- care management delivered using simple telephone technology Chronic heart failure (CHF) specialized disease management pro- (data may have been collected and stored by a computer). Telemo- grammes improve survival and quality of life, reduce rehospitaliza- nitoring (TM) is digital/broadband/satellite/wireless, or blue-tooth transmission of physiological data e.g. electrocardiogram, blood practice.However, most of the successful CHF disease manage- pressure, weight, pulse oximetry, respiratory rate, and other data ment programmes have been built around close clinical follow-up.
(self-care, education, lifestyle modification, and medicine adminis- The need for intense face-to-face follow-up strategies limits the tration). Both models of care have the potential to provide number of patients who can participate in these programmes.
access to specialist care for a much larger number of patientsacross a much greater geography and might reduce the costs ofcare. These systems can assist directly in patient management, Table 1 Inclusion and exclusion criteria.
transferring the burden of care from health professionals andinvolve the patient in supported self-care.However, it is still not clear as to whether or not these interventions when delivered as the sole disease management intervention improve patient Randomized controlled trials Full peer-reviewed publication (primary This review, published in the Cochrane Database of Systematic meta-analysis of primary outcomes) Reviews updates a previously published review of remote Participants with a definitive diagnosis of heart monitoring strategies for CHF that included 10 trials of STS and failure, aged ≥18 years five of TM.Since the first review, a number of large trials have Recently discharged from an acute care setting to been published reporting outcomes on both STS and TM. We home (excluding nursing homes or have focused on the same primary outcomes (all-cause mortality, convalescent homes) or recruited whilemanaged in the community setting CHF-related hospitalization, and all-cause hospitalization) and sec- Structured scheduled telephone support or ondary outcomes: length of stay, health-related quality of life, telemonitoring (daily, weekly, and monthly) healthcare costs, and acceptability of the intervention to patients Initiated by a healthcare professional (medical, with CHF. Specifically, we have examined the benefits of STS or nursing, social work, pharmacist).
TM on a number of important outcomes in patients with CHF Delivered as the only heart failure disease when compared with standard care, where STS or TM is the management intervention, without home-visits primary model of specialized disease-management intervention.
or intensified clinic follow-up Targeted towards the patient, and not caregivers Did not include any visits at home by a specialized CHF healthcare professional or study personnelfor the purpose of education or clinical As per our protocolwe applied the Cochrane methodologyfor this assessment other than an initial visit to set-up review.The specific eligibility criteria of included studies are pre- Consisted of standard post-discharge care without intensified attendance at cardiology clinics orclinic-based CHF disease management Information sources and search strategies programme or home-visits As per the Cochrane Heart Group protocol,all known relevant search All-cause mortality, CHF-related or all-cause engines and electronic databases were utilized for the review update hospitalizations, length of stay, cost of the period from January 2006 to November 2008. These included intervention or cost reductions, quality of life, CENTRAL; MEDLINE; EMBASE; CINAHL; AMED; Science Citation acceptability, and adherence Index Expanded; DARE; no date limit: National Research Register; Exclusion criteria IEEE Xplore; OAIster; Google Scholar; Informit; Vivisimo; Australian Digital Theses Programme, and Proquest Digital Dissertations. Bibliogra- No primary or secondary outcomes of interest reported or available from the study authors phies of relevant studies and systematic reviews were hand-searched.
Abstracts from the following conferences were also hand-searched for Not specific to heart failure the years 2006, 2007, and 2008: European Society of Cardiology (ESC) Studies could not include any home-visits by specialized CHF health Congress; American College of Cardiology Annual Scientific Sessions; professionals or study personnel for the purpose of education orclinical assessment or include intensified clinic follow-up American Heart Association Scientific Sessions; Heart Failure Societyof America Annual Scientific Meeting; ESC Heart Failure Congress;ESC Spring Meeting of Cardiovascular Nursing; World Congress of Car- Copyright Cochrane Collaboration, reproduced with permission.
diology (2006, 2008); and the Asia-Pacific Heart Failure Congress (2008).
S.C. Inglis et al.
Keywords included: heart failure, cardiac failure, telehealth, tele- STS and TM intervention arms compared with usual care.
phone, telemonitoring and disease-management. Language restrictions The included populations were from seven countries (Table were not applied. Full details of search strategies are a Twenty-five studies were published as full peer-reviewed publi- cations (16 STS, n ¼ 5613 and 11 TM, n ¼ 2710). Two studies had two separate intervention arms (STS vs. TM vs. usual care) and Randomized controlled trials (RCT) of STS or TM compared with each was considered as a separate comparison with usual care (and usual care were eligible to be included in the meta-analysis if they are included in the aforementioned counts). One study included were published in full in a peer-reviewed journal.Studies that were two STS arms, one of which used standard telephone equipment published as abstracts only were included in sensitivity and the other a videophone; for our analyses these two interven- This decision was supported by a publication, co-authored by a tion arms were combined as member of this review team, which demonstrated that substantialpotential discrepancies between results presented in meeting abstractscompared with final peer-reviewed Risk of biasAnalysis of the distribution in the funnel plots (not shown) demon- Data collection process strated a strong publication bias towards positive outcomes in the Two expert reviewers (S.C.I. and R.A.C.) independently reviewed the included stuA summary of the risk of bias analysis is pre- results of each search according to the inclusion and exclusion criteria sented in Table The heterogeneity within the studies ranged with a standardized data extraction tool and also applied standard from low (for all-cause mortality, I2 ¼ 0%) to substantial (for all- scales to judge study quality and risk of A third reviewer cause hospitalizations, STS I2 ¼ 24%; TM I2 ¼ 78%) (Figures – ) (I2 statistic low ¼ 0 – 40%; moderate ¼ 30 – 60%; substantial ¼50 – 90%, considerable ¼ 75 – Data and analysisMeta-analyses All-cause mortality CHF-related, and all-cause hospitalizations) were performed according Fifteen studies of STS– – and 11 studies to Mantel – Haenzel methods, using a fixed effects model, risk ratios of ,– measured the effect on the risk of all- (RR), intention-to-treat, and assessment of statistical heterogeneity cause mortality (Figure Telemonitoring was effective in reducing using the I2 statistic.All analyses were performed using ReviewManager (RevMan) Version 5.0 (Copenhagen: The Nordic Cochrane the risk of all-cause mortality in patients with CHF, with a 34% Centre, Cochrane Collaboration, Secondary outcomes such reduction in the risk of mortality observed [RR 0.66 95% confi- as quality of life, cost effectiveness and adherence and acceptance dence interval (CI) 0.54 – 0.81, P , 0.0001, I2 ¼ 0%]. A similar were measured using multiple tools across the studies. To summarize non-significant trend was noted for STS [RR 0.88 (95% CI 0.76 – these outcomes results have been tabulated and described. Due to 1.01), P ¼ 0.08, I2 ¼ 0%].
variances in the way length of stay was calculated and reported in Addition of studies published as abstractshad no sub- the included studies, this outcome was tabulated as opposed to stantial impact on the results [STS: RR 0.85, (95% CI 0.75 – 0.97), pooled into a meta-analysis.
I2 ¼ 0%, P ¼ 0.02; TM: RR 0.68, (95% CI 0.57 – 0.82), I2 ¼ 0%,P , 0.0001] nor did exclusion of studies lasting 6 months Sensitivity analysis or less[STS: RR 0.87, (95% CI 0.74 – 1.02), Data from included studies published only as abstracts were added to I2 ¼ 0%, P ¼ 0.08; TM: RR 0.69, (95% CI 0.55 – 0.86), P ¼ 0.0009, the meta-analyses of the primary outcomes to assess whether publi- cation status made any difference to the result, including the level ofheterogeneity. A second sensitivity analysis was performed to assess Chronic heart failure-related the impact of length of follow-up on the primary outcomes for fullpeer-reviewed publications only, excluding studies with a follow-up period of 6 months or less.
Thirteen studies of STS– and four studies ofexamined the effect of these interventions on the risk of CHF-related hospitalization (Figure ). Structured telephonesupport reduced the proportion of patients hospitalized due toCHF by 23% [RR 0.77, (95% CI 0.68 – 0.87), P , 0.0001, I2 ¼ 7%] and TM reduced this by 21% [RR 0.79, (95% CI 0.67 – 0.94), P ¼ Overall, 322 publications from 7952 citations were identified as 0.008, I2 ¼ 39%].
potentially relevant studies and full copies were retrieved and Addition of one STS study published as an abstracdid not alter assessed. Exclusions are detailed in Figure the result of the meta-analysis other than to reduce heterogeneity(I2 ¼ 0%). Addition of two TM studies published as abstracts Study characteristics to the meta-analysis marginally improved the effect [RR 0.76, (95% Thirty RCTs of STS and TM were identified, which included CI 0.64 – 0.89), P ¼ 0.0006; I2 ¼ 34%]. Excluding studies with a 9560 participants (Table These include 16 studies of follow-up period of 6 months or less– did not change the results of the meta-analyses [STS: RR 0.76, (95% CI 0.65 – abstracts12 studies of – – (three of which 0.89), P ¼ 0.0005; I2 ¼ 0%]. All TM studies reporting CHF-related were published abstracts), and two studies with both hospitalizations had a follow-up period . 6 months.


Outcomes of STS or TM as the primary component of CHF management Figure 1 Study selection flowCopyright Cochrane Collaboration, reproduced with permission.
No substantial change was observed in the results of the Eleven studies of STS–and eight studies of added,[STS: RR 0.90 (95% 0.84 – 0.97), P ¼ 0.003, I2 ¼ 32%; –examined the effect of these interventions on TM: RR 0.94, (95% CI 0.87 – 1.01), P ¼ 0.09, I2 ¼ 73%]. Excluding the proportion of participants with at least one hospitalization for any cause (Figure The effect of STS and TM on the risk of did not substantially change the outcome a hospitalization was similar [STS: RR 0.92, (95% CI 0.85– 0.99), P ¼ [STS: RR 0.91, (95% CI 0.83 – 0.99), P ¼ 0.03; I2 ¼ 22%; TM: RR 0.02, I2 ¼ 24%; TM: RR 0.91, (95% CI 0.84–0.99), P ¼ 0.02, I2 ¼ 78%].
0.87, (95% 0.80 – 0.95), P ¼ 0.002, I2 ¼ 85%].
Table 2 Description of included studies.
Structured telephone support vs. usual care; telemonitoring vs. usual care Cleland et al. (2005) STS: education and monitoring.
Mortality, hospitalizations, length of stay, adaptation, and acceptance of the intervention TM: weight, BP, ECG Mortara et al. (2009) HHH STS: education and monitoring UK, Poland, Italy Mortality, hospitalizations, bed-days, adherence to the TM: weight, BP and symptoms Structured telephone support vs. usual care Angermann et al. (2007) Education and monitoring Mortality, days alive and out of hospital, NYHA functional INH study [Abstra class, and quality of life Education and monitoring Mortality, unexpected visits, hospitalizations, cost, and DeBusk et al. (2004) CHF lifestyle education and Mortality, hospitalizations, emergency and outpatient medication management visits, prescription of recommended pharmacotherapy DeWalt et al. (2006) Education and monitoring Mortality, hospitalizations, quality of life, heart failure self-efficacy, heart failure knowledge, weightmonitoring Galbreath et al. (20– Education and monitoring Mortality, 6-min walk test, NYHA functional class, quality of life, and cost. Subgroup: ejection fraction andmedication adherence Gattis et al. (1999) PHARM Pharmacist-led medication review Mortality, hospitalization and medication prescription GESICA Investigators Education and monitoring Mortality, hospitalizations, quality of life, and medication Tonkin et al. (2009) CHAT Telewatch system (Baltimore) Mortality, hospitalizations, adherence to, adaptation, and acceptance of intervention Education and monitoring Mortality, hospitalizations, costs, medication prescription, and adherence Pharmacist-led medication review, Mortality, hospitalizations, and NYHA functional class Ramachandran et al.
Education, monitoring, and Hospitalizations, NYHA functional class, quality of life, medication management medication prescription, and cost Education and counselling Mortality, hospitalizations, hospital days, physician and emergency department visits, cost, and patient Education, monitoring, and Mortality, hospitalizations, cost, quality of life, and Sisk et al. (2006 Patient assessment and education Mortality, hospitalizations, cost, and quality of life Tsuyuki et al. (2004 Education and monitoring Mortality, hospitalizations, medication adherence, physician and emergency department visits, and cost Wakefield et al. Education and monitoring Mortality, hospitalizations, hospital days, time to first readmission, urgent care clinic visits, quality of life,satisfaction, and cost Telemonitoring vs. usual care Antonicelli et al. (20 BP, HR, weight and 24h urine Mortality, hospitalizations, and quality of life Hospital days, days alive and out of hospital, quality of life, heart failure knowledge, cost, acceptance, andself-care Blum et al. (2007) Weight, BP, HR, rhythm Hospitalizations, quality of life, mortality, and BNP Capomolla et al. (2004) Weight, systolic BP, HR Mortality, hospitalizations, adherence, and emergency department visits de Lusignan et al. (2001) Pulse, BP, weight Mortality, satisfaction, adherence, and quality of life Giordano et al. (2009) Mortality, hospitalizations, haemodynamic instability episode occurrence, and cost Goldberg et al. (2003) Weight and symptoms Mortality, hospitalizations, emergency department visits, quality of life, and adherence to the intervention Kielblock et al. (20 Mortality, length of stay, hospital and drug costs, total costs per patient, satisfaction, hospitalizations, andmedication prescription Villani et al. (2007) Weight, urine output, fluid intake, Mortality, hospitalizations, emergency room visits, and hospital days per patient Weight and symptoms Mortality, hospitalizations, length of hospital stay, emergency room visits, quality of life, and adherenceto the intervention Woodend et al. (2008) Mortality, hospitalizations, quality of life, emergency department visits, hospital days, and patientsatisfaction Zugck et al. (2008) HiTel Weight, BP, 12-lead ECG Mortality, hospitalizations, and length of stay Copyright Cochrane Collaboration, reproduced with permission.
S.C. Inglis et al.
Table 3 Assessment of bias of included studies.
Adequate allocation Adequate blinding of Free of selective outcome assessors Structured telephone support vs. usual care; telemonitoring vs. usual care Cleland et al. (2005) Mortara et al. (2009) HHH Structured telephone support vs. usual care Angermann et al. (2007) INH study [Abstract] DeBusk et al. (2004) DeWalt et al. (2006) Galbreath et al. (2004) Gattis et al. (1999) GESICA Investigators Tonkin et al. (2009) CHAT Laramee et al. (2003) Ramachandran et al.
Riegel et al. (2006) Sisk et al. (2006) Wakefield et al. (2008) Telemonitoring vs. usual care Antonicelli et al. (2008) Balk et al. (2008) Blum et al. (2007) Capomolla et al. (2004) de Lusignan et al. (2001) Giordano et al. (2009) Goldberg et al. (2003) Kielblock et al. (2007) Villani et al (2007) ICARUS Soran et al. (2008) Woodend et al. (2008) Zugck et al. (2008) HiTel Copyright Cochrane Collaboration, reproduced with permission.
Health-related quality of life Only one STS reported a statistically significant reduction in the length of stay for patients in the intervention group com- These were either a direct comparison between the inter- pared with those receiving usual care. One study reported a sub- vention and control groups at study conclusion, or between baseline stantial difference in the number of hospital days per pat and study conclusion within the study arm. A range of psychometric


Outcomes of STS or TM as the primary component of CHF management Figure 2 Effect of structured telephone support and telemonitoring on all-cause mortalityCopyright Cochrane Collaboration, reproducedwith permission.
tools were used [Chronic Heart Failure Symptomatology Question- of the interventions varied according to the type of intervention, naire; Minnesota Living with Heart Failure Questionnaire (MLWHFQ); in particular the technologies used and the intensity at which it Kansas City Cardiomyopathy Questionnaire (KCCM); Short-Form-12 was delivered. Of the 11 studies which reported the effect of Item; Short-Form-36 Item (SF-36); Health Distress Score].
the intervention on the cost of ,– all Six studies of STSreported improvements in but three,reported reductions in cost (either cost per quality of life, with significant improvements in physical (P ¼ admission or overall reduction in healthcare costs), with those and overall measures (MLWHFQ and KCCM). Three TM reporting per cent reductions ranging between 14%and 86%.
(MLWHFQ P ¼ 0.001 and SF-36 mental (P ¼ 0.001), and physical component scores (P ¼ 0.003);MLWHFQ P ¼ 0.025,and Few studies reported adherence to the intervention (compliance).
SF-36 P , SF-36 health perception P ¼ 0.046 Among those that did,adherence was measured at65.8% for STS,and 75% to 98.5% for The adap- tation to the technology was high, with two studies, reporting Twelve studies (nine STS– – and three ) that 96 – 97% of patients (often aged .70 years) were able to provided details on cost of the intervention or cost reductions learn and use the STS or TM systems.Acceptance (satisfac- associated with the intervention or cost effectiveness. The cost tion) of patients receiving healthcare via STS or TM was rated


S.C. Inglis et al.
Figure 3 Effect of structured telephone support and telemonitoring on CHF-related hospitalizations.Copyright Cochrane Collaboration,reproduced with permission.
between 76%and ,Improvements in other out- interventions produce these effects are unclear but probably comes from these trials included: New York Heart Association reflect a combination of improved implementation of and adher- (NYHA) functional class that improved in threestudies.
ence to guideline therapies, early identification of complications Chronic heart failure knowledge and self-care improved in both or disease progression, and a positive impact on patient psychol- studies reporting this 6 min walk test improved in ogy.Patients in these trials reported a sense of reassurance one study,of the twothat reported this outcome; improve- and security, feeling that they have a lifeline to expert care.
Two substantial have been reported since this sixof the seven stuthat reported this review was completed and will be incorporated in the next revi- outcome and the only study to report brain natriuretic peptide, sion which is currently underway. The Tele-HF studywhich reported an improvement in this included 1653 patients, was a study of a voice interactive system(STS) applied to patients recently discharged from hospital after an episode of worsening heart failure. Adherence with thesystem was very poor, suggesting that patients did not engage This systematic review and meta-analysis suggests that both TM with the service, perhaps because of the nature of the technology.
and STS have a broad range of benefits for patients with heart No benefits were observed on death or hospitalization. This is failure: including a substantial reduction in all-cause mortality for consistent with the results of our systematic review,at least TM, a substantial reduction in the risk of CHF hospitalization for with respect to mortality. The TIM-HF study,including 710 both TM and STS and a modest reduction in the risk of all-cause patients, was a TM study of patients with exceptionally well- hospitalization. These interventions improved quality of life, managed chronic stable heart failure monitored by a remote reduced costs, and were acceptable to patients. Improvements in expert group. Trends to fewer deaths and hospitalizations with prescribing, patient knowledge and self-care, and functional class TM were not significant; suggesting that home TM might not be were observed. The precise mechanisms by which these an effective intervention in stable patients when other systems


Outcomes of STS or TM as the primary component of CHF management Figure 4 Effect of structured telephone support and telemonitoring on all-cause hospitalizatCopyright Cochrane Collaboration, repro-duced with permission.
have ensured a high quality of care. However, TM might be a more with redeployment of existing staff rather than an expansion of efficient and less expensive option when the quality of care is not the healthcare work force required by other strategies. Indeed, it of a similar standard to that provided in TIM-HF. Also, it is unclear is quite likely that TM has not worked optimally in clinical trials as to whether home TM is most successfully deployed as an since the studies were generally done in parallel to rather than adjunct to personalized care from a local specialist clinic or as a integrated with existing services. Restructuring healthcare around remote a regional or national service.
TM could be more effective and cost efficient.
We excluded from this analysis other methods of follow-up and An additional and increasingly apparent dimension to TM is that management that have also been reported to improve outcomes, it is a direct investment in the patient rather than in healthcare ser- such as nurse-led or specialist heart failure clinic or home vices. The patient is less likely to be a passive recipient of services It is possible that intensified self-management and remote man- from health professionals, and becomes more actively involved in agement are the key factors driving clinical benefit with these inter- their care. Patients provide information on symptoms and vital ventions. If so, the main issues revolve around an organization and signs and receive feedback and education, which they can review cost effectiveness. The most expensive aspect of healthcare in at their leisure as often as they wish and together with their high-income countries is staff to run services and deliver care. Deli- carers and family. More advanced systems will ensure that the vering care by increasing direct one-to-one interactions is likely to patients know when and how medication should be adjusted and be an expensive long-term strategy. Development of TM systems when they can do this themselves and when they need professional that support the patient directly in making decisions about issues support. Because the patients know what care they should receive, such as diuretic dose, diet, and life-style and when to seek pro- health professionals may be more likely to deliver it or explain why fessional advice have the potential to offer expert care to most the patients should deviate from the plan. Telemonitoring will patients with CHF. Implementation of TM will require a change create more expert patients. Undoubtedly, this will create head- in the approach of healthcare systems to the delivery of care aches for health professionals, leading to resistance to change.
S.C. Inglis et al.
The medical profession should offer the best service to patients evidence and the impact on hospitalization that is likely to mitigate even if this means moving out of their professional comfort zone.
costs, all patients with CHF should have access to enhanced Compared with other recent systematic reviews of remote monitoring in CHF,our revis unique in using robustCochrane methodologyWe have synthesized and quantified the benefits of STS and TM, while limiting the influence of con- This paper is based on a Cochrane review first published in The founders such as home-visits by specialized healthcare staff or fre- Cochrane Database of Systematic Reviews (CDSR) 2010, Issue 8 quent visits to a specialized CHF clinic on the efficacy of these (see www.thecochranelibrary.com for information). Cochrane interventions in managing patients with CHF. Previous reviews reviews are regularly updated as new evidence emerges and in on this topic have included a mixture of research methods response to feedback, and the CDSR should be consulted for (RCTs and cohort studies) and studies of both invasive and non- the most recent version of the review.
invasive remote monitoring, many of which have involved home We wish to acknowledge the valuable contribution of the fol- lowing researchers who contributed to this review: Dr Christian These findings have important clinical implications. The findings Lewinter and Dr Damien Cullington from academic unit of cardi- of this review are highly relevant to the future planning and ology, Castle Hill Hospital, East Yorkshire, United Kingdom for implementation of CHF disease-management globally. This analysis retrieving studies and undertaking hand-searching; Ms Jocasta Ball provides strong evidence that these technologies reduce mortality from Baker IDI Heart and Diabetes Institute, Melbourne, Australia and hospitalizations as well as improving measures such as quality for assistance with retrieving studies and entering study details into of life. There may be benefits of using these technologies to a bibliography and Ms Stefanie Nagendirarajah from Baker IDI manage patients with CHF that relate to human or financial Heart and Diabetes Institute, Melbourne, Australia for assistance resources, but perhaps the biggest advantage can be gained from with retrieving studies. We would also like to thank the staff at utilizing these technologies to reach patients with CHF who are the Cochrane Collaboration Heart Review Group, in particular, without access to home or clinic-based CHF-management pro- Dr Joey Kwong, Managing Editor, and Miss Claire Williams, Assist- Such benefits may not be restricted to high-income ant Managing Editor. We would like to also thank Ms Monika Win- countries. Indeed, China and both have programmes for terstein, Mr Horst Winterstein, Mrs Erika Winterstein, and delivering care remotely.
Ms Andrea Horsky for their assistance with German translations.
The average age of patients in these included trials ranged from Our team also wishes to make special acknowledgement to the 45 to 78 years, with the majority of patients aged .68 years. It is contribution of the following librarians for their assistance with clear that many older people are able to use and benefit from STS designing and conducting the searches: Ms Margaret Burke and TM. In fact TM devices are usually designed specifically with (Cochrane Heart Review Group Trial Search Coordinator), older people in mind.
Dr Helen Marlborough (Medical Science Librarian, University of Our synthesis of the evidence of STS and TM is only as good as Glasgow); Ms Margaret Goedhart (Health Sciences Librarian, Uni- the included studies. We were limited by the format of published versity of South Australia). We also acknowledge the following results, especially for those where we were unsuccessful in obtain- study authors who were very generous in sharing further details ing further study details. In addition, the heterogeneity is large for of their studies and data, some of which is unpublished, in order some of the meta-analyses of the primary outcomes. This hetero- to include the most up-to-date data in our meta-analysis: CE geneity is not only within methodology but also the types and Angermann, K Blum; DA DeWalt; M Blasius; P Brocki; S Kottmair; intensity of applied technologies.
WA Gattis; LR Goldberg; A Laramee; A Mortarra; G Parati; B There was evidence of publication bias. It is likely that many Riegel; RT Tsuyuki; BJ Wakefield; R Cebola and D Schellberg.
small studies are never published, either because the investigatordoes not offer their results for publication or because editors reject under-powered and negative studies. There is a dearth of This study received no external funding. All authors had full access to evidence about how long patients should be supported by TM all the data in the study and had final responsibility for the decision to or STS. It is possible that the greatest benefit in terms of education submit for publication. S.C.I. is a Post-Doctoral Research Fellow sup- and medication patterns is accrued within a few weeks and that ported by the National Health and Medical Research Council of Aus-tralia (NHMRC) and National Heart Foundation of Australia (NHMRC long-term monitoring is redundant. However, the weight monitor- Grant ID 472 699). R.A.C. is a Post-Doctoral Research Fellow sup- ing in heart failure trial showed that a 6-month TM intervention ported by the NHMRC (NHMRC Grant ID 570 141) and a Research was associated with a reduction in mortality but that withdrawal SA Fellowship. S.S. is a Senior Research Fellow supported by the led to rapid loss of this initial benefit, suggesting that long-term NHMRC (NHMRC Grant ID 472 658). F.A.M. receives salary TM might be superior to short-term TM.
support from the Alberta Heritage Foundation for Medical Research In conclusion, STS and TM improve outcomes for patients with Health Scholar Program and the University of Alberta/Merck Frost/ CHF, although only TM appears to have a substantial impact on Aventis Chair in Patient Health Management.
reducing mortality. This may reflect the impact of improvedaccess to specialist care, which could be delivered by more con- Conflict of interest ventional means but at additional cost. The effects appear substan-tial and might be an underestimate of the true impact when J.G.F.C. has received funds from Philips and Bosch, which have a properly integrated into care pathways. Given the wealth of commercial interest in telemonitoring, for research staff and fees Outcomes of STS or TM as the primary component of CHF management for consulting and has acted as a paid advisor on the subject of this improvements in patients with congestive heart failure: evidence from a random- review. J.G.F.C. was involved in the design, conduct and publication ized trial in community-dwelling patients. Am J Manag Care 2005;11:701 – 713.
20. Smith B, Hughes-Cromwick PF, Forkner E, Galbreath AD. Cost-effectiveness of of a study included in this review. S.S. was involved in the design telephonic disease management in heart failure. Am J Manag Care 2008;14: and publication of a study included in this review. R.A.C. was 106 – l15.
involved in the conduct and publication of a study included in 21. Gattis WA, Hasselblad V, Whellan DJ, O'Connor CM. Reduction in heart failure events by the addition of a clinical pharmacist to the heart failure management this review. No other funding was received to support this project.
team: results of the Pharmacist in Heart Failure Assessment Recommendationand Monitoring (PHARM) Study. Arch Intern Med 1999;159:1939 – 1945.
22. GESICA Investigators. Randomised trial of telephone intervention in chronic heart failure: DIAL trial. BMJ 2005;331:425 – 427.
23. Tonkin A, Yallop J, Driscoll A, Forbes A, Croucher J, Chan B, Stewart S, Clark R, 1. Gonseth J, Guallar-Castillon P, Banegas JR, Rodriguez-Artalejo F. The effectiveness Huynh L, Meehan A, Egan H, Piterman L, Kasper E, Krum H. Does telephone of disease management programmes in reducing hospital re-admission in older support of the rural and remote patients with heart failure improve clinical out- patients with heart failure: a systematic review and meta-analysis of published comes? Results of the Chronic Heart Failure Assistance by Telephone Study reports. Eur Heart J 2004;25:1570 – 1595.
(CHAT) Study (abstract). Heart Lung Circ 2009;18S:S105.
2. McAlister FA, Stewart S, Ferrua S, McMurray J. Multidisciplinary strategies for the 24. Clark RA, Yallop JJ, Piterman L, Croucher J, Tonkin A, Stewart S, Krum H, CHAT management of heart failure patients at high risk for admission—a systematic Study Team. Adherence, adaptation and acceptance of elderly chronic heart review of randomized trials. J Am Coll Cardiol 2004;44:810 – 819.
failure patients to receiving healthcare via telephone-monitoring. Eur J Heart Fail 3. Jaarsma T, Stromberg A, De Geest S, Fridlund B, Heikkila J, Ma˚rtensson J, 2007;9:1104 – 1111.
Moons P, Scholte op Reimer W, Smith K, Stewart S, Thompson DR. Heart 25. Laramee AS, Levinsky SK, Sargent J, Ross R, Callas P. Case management in a het- failure management programmes in Europe. Eur J Cardiovasc Nurs 2006;5: erogeneous congestive heart failure population: a randomized controlled trial.
197 – 205.
Arch Intern Med 2003;163:809 – 817.
4. Clark RA, Driscoll A, Nottage J, McLennan S, Coombe DM, Bamford EJ, 26. Rainville EC. Impact of pharmacist interventions on hospital readmissions for Wilkinson D, Stewart S. Inequitable provision of optimal services for patients heart failure. Am J Health Syst Pharm 1999;56:1339 – 1342.
with chronic heart failure: a national geo-mapping study. Med J Aust 2007;186: 27. Ramachandran K, Husain N, Maikhuri R, Seth S, Vij A, Kumar M, Srivastava N, 169 – 174.
Prabhakaran D, Airan B, Reddy KS. Impact of a comprehensive telephone-based 5. Clark RA, Inglis SC, McAlister FA, Cleland JGF, Stewart S. Telemonitoring or disease management programme on quality-of-life in patients with heart failure.
structured telephone support programmes for patients with chronic heart Natl Med J India 2007;20:67 – 73.
failure: systematic review and meta-analysis. BMJ 2007;334:942 – 945.
28. Riegel B, Carlson B, Kopp Z, LePetri B, Glaser D, Unger A. Effect of a standar- 6. Taylor S, Bestall J, Cotter S, Falshaw M, Hood S, Parsons S, Wood L, dized nurse case-management telephone intervention on resource use in patients Underwood M. Clinical service organisation for heart failure. Cochrane Database with chronic heart failure. Arch Intern Med 2002;162:705 – 712.
Syst Rev 2005, Issue 2. Art. No. CD002752.
29. Riegel B, Carlson B, Glaser D, Romero T. Randomized controlled trial of tele- 7. Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, phone case management in Hispanics of Mexican origin with heart failure.
Cleland JG. Structured telephone support or telemonitoring programmes for J Card Fail 2006;12:211 – 219.
patients with chronic heart failure. Cochrane Database Syst Rev 2010, Issue 8.
30. Sisk JE, Hebert PL, Horowitz CR, McLaughlin MA, Wang JJ, Chassin MR. Effects of Art. No. CD007228.
nurse management on the quality of heart failure care in minority communities: a 8. Inglis SC, Clark RA, Cleland JGF, McAlister F, Stewart S. Structured telephone randomized trial. Ann Intern Med 2006;145:273 – 283.
support or telemonitoring programs for patients with chronic heart failure.
31. Hebert PL, Sisk JE, Wang JJ, Tuzzio L, Casabianca JM, Chassin MR, Horowitz C, Cochrane Database Syst Rev 2008, Issue 3. Art. No. CD007228.
McLaughlin MA. Cost-effectiveness of nurse-led disease management for heart 9. Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions failure in an ethnically diverse urban community. Annal Intern Med 2008;149: Version 5.0.1 [updated September 2008]. www.cochrane-handbook.org The 540 – 548.
Cochrane Collaboration, 2008.
32. Tsuyuki RT, Fradette M, Johnson JA, Bungard TJ, Eurich DT, Ashton T, 10. Toma M, McAlister FA, Bialy L, Adams D, Vandermeer B, Armstrong PW. Tran- sition from meeting abstract to full-length journal article for randomized con- Gordon W, Ikuta R, Kornder J, Mackay E, Manyari D, O'Reilly K, Semchuk W.
trolled trial. JAMA 2006;295:1281 – 1287.
A multicenter disease management program for hospitalized patients with 11. Cleland JG, Louis AA, Rigby AS, Janssens U, Balk AH. Non-invasive home telemo- heart failure. J Card Fail 2004;10:473 – 480.
nitoring for patients with heart failure at high risk of recurrent admission and 33. Wakefield BJ, Ward MM, Holman JE, Ray A, Scherubel M, Burns TL, Kienzle MG, Rosenthal GE. Evaluation of home telehealth following hospitalization for heart (TEN-HMS) study. J Am Coll Cardiol 2005;45:1654 – 1664.
failure: a randomized trial. Telemed J E Health 2008;14:753 – 761.
12. Louis AA, Balk A, Janssens U, Westerteicher C, Cleland JG. Patient acceptance 34. Antonicelli R, Testarmata P, Spazzafumo L, Gagliardi C, Bilo G, Valentini M, and satisfaction of home telemonitoring in the management of heart failure: Olivieri F, Parati G. Impact of telemonitoring at home on the management of TENS-HMS (abstract). JACC 2002;19:537A.
elderly patients with congestive heart failure. J Telemed Telecare 2008;14: 13. Mortara A, Pinna GD, Johnson P, Maestri R, Capomolla S, La Rovere MT, 300 – 305.
Ponikowski P, Tavazzi L, Sleight P, HHH Investigators. Home telemonitoring in 35. Balk AH, Davidse W, Dommelen P, Klaassen E, Caliskan K, van der Burgh P, heart failure patients: the HHH study (Home or Hospital in Heart Failure). Eur Leenders CM. Tele-guidance of chronic heart failure patients enhances knowl- J Heart Fail 2009;11:312 – 318.
edge about the disease. A multi-centre, randomised controlled study. Eur J 14. Angermann CE, Stork S, Gelbrich G, Faller H, Jahns R, Frantz S, Ertl G. A prospec- Heart Fail 2008;10:1136 – 1142.
tive randomized controlled trial comparing the efficacy of a standardized, suprar- 36. Blum K, Gottlieb S. Morbidity and mortality benefits of reliable instrumental egionally transferable program for monitoring and education of patients with support (abstract). J Cardiac Fail 2007;13:S164.
systolic heart failure with usual care—the Interdisciplinary Network for Heart 37. Blum K, Janowick F, Gottlieb SS. One year changes in quality of life for heart Failure (INH) Study (abstract). Circ, 2007;116(II):601.
failure patients in a home telemonitoring program (abstract). J Cardiac Fail, 15. Barth V. A nurse-managed discharge program for congestive heart failure patients: outcomes and costs. Home Health Care Manag Pract 2001;l:436 – 43.
38. Capomolla S, Pinna G, La Rovere MT, Maestri R, Ceresa M, Ferrari M, Febo O, 16. DeBusk RF, Miller NH, Parker KM, Bandura A, Kraemer HC, Cher DJ, West JA, Caporotondi A, Guazzotti G, Lenta F, Baldin S, Mortara A, Cobelli F. Heart Fowler MB, Greenwald G. Care management for low-risk patients with heart failure case disease management program: a pilot study of home telemonitoring failure: a randomized, controlled trial. Ann Intern Med 2004;141:606 – 613.
versus usual care. Eur Heart J Suppl 2004;6:F91 – 98.
17. DeWalt DA, Malone RM, Bryant ME, Kosnar MC, Corr KE, Rothman RL, 39. de Lusignan S, Wells S, Johnson P, Meredith K, Leatham E. Compliance and effec- Sueta CA, Pignone MP. A heart failure self-management program for patients tiveness of 1 year's home telemonitoring. The report of a pilot study of patients of all literacy levels: a randomized, controlled trial. BMC Health Serv Res 2006;6:30.
with chronic heart failure. Eur J Heart Fail 2001;3:723 – 730.
18. Galbreath AD, Krasuski RA, Smith B, Stajduhar KC, Kwan MD, Ellis R, 40. Giordano A, Scalvini S, Zanelli E, Corra U, Longobardi GL, Ricci VA, Baiardi P, Freeman GL. Long-term healthcare and cost outcomes of disease management Glisenti F. Multicenter randomised trial on home-based telemanagement to in a large, randomized, community-based population with heart failure. Circulation prevent hospital readmission of patients with chronic heart failure. Int J Cardiol 2004;110:3518 – 3526.
2009;131:192 – 199.
19. Smith B, Forkner E, Zaslow B, Krasuski RA, Stajduhar K, Kwan M, Ellis R, 41. Goldberg LR, Piette JD, Walsh MN, Frank TA, Jaski BE, Smith AL, Rodriguez R, Galbreath AD, Freeman GL. Disease management produces limited quality-of-life Mancini DM, Hopton LA, Orav EJ, Loh E, WHARF Investigators. Randomized S.C. Inglis et al.
trial of a daily electronic home monitoring system in patients with advanced heart 50. Kohler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bo¨hm M, Boll H, failure: the Weight Monitoring in Heart Failure (WHARF) trial. Am Heart J 2003; Gelbrich G, Kirwan B, Anker SD. Telemedical Interventional Monitoring in 146:705 – 712.
Heart Failure (TIM-HF), a Randomized, Controlled Intervention Trial Investigating 42. Kielblock B, Frye C, Kottmair S, Hudler T, Siegmund-Schultze E, Middeke M.
the Impact of Telemedicine on Mortality in Ambulatory Patients With Chronic Impact of telemetric management on overall treatment costs and mortality rate Heart Failure (abstract). Circ 2010;122:2215 – 2226.
among patients with chronic heart failure. Dtsch Med Wochenschr 2007;132: 51. Inglis SC, Clark RA, Cleland JGF. Telemonitoring in patients with heart failure.
417 – 422.
Letter to the Editor. N Engl J Med 2011;364:1078 – 1079.
43. Villani A, Malfatto G, Della Rosa F, Branzi G, Boarin S, Borghi C, Cosentino E, 52. Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Kim SS, Gualerzi M, Coruzzi P, Molinari E, Compare A, Cassi M, Collatina S, Parati G.
Koehler K, Lucke S, Honold M, Heinze P, Schweizer T, Braecklein M, Kirwan B, Disease management for heart failure patients: role of wireless technologies for Gelbrich G, Anker SD on behalf of the TIM-HF Investigators. Telemedical Inter- telemedicine. The ICAROS project (abstract). G Ital Cardiol 2007;8:107 – 114.
ventional Monitoring in Heart Failure (TIM-HF), a randomized, controlled 44. Soran OZ, Pina IL, Lamas GA, Kelsey SF, Selzer F, Pilotte J, Lave JR, Feldman AM.
intervention trial investigating the impact of telemedicine on mortality in ambulat- A randomized clinical trial of the clinical effects of enhanced heart failure moni- ory patients with heart failure: study design. Eur J Heart Fail 2010;12: toring using a computer-based telephonic monitoring system in older minorities 1354 – 1362.
and women. J Card Fail 2008;14:711 – 717 53. Cleland JGF, Coletta AP, Buga L, Antony R, Pellicori P, Freemantle N, Clark AL.
45. Woodend AK, Sherrard H, Fraser M, Stuewe L, Cheung T, Struthers C. Telehome Clinical trials update from the American Heart Association Meeting 2010: monitoring in patients with cardiac disease who are at high risk of readmission.
Heart Lung 2008;37:36 – 45.
PROTECT. Eur J Heart Fail 2011 (April issue).
46. Woodend AK, Sherrard H, Fraser M, Stuewe L, Haddad H, Cheung T, 54. Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A. Meta-Analysis of Struthers C. Getting connected: telehome care for patients with heart disease.
remote monitoring of heart failure patients. J Am Coll Cardiol 2009;54:1683 – 1694.
Can Home Econ J 2003;52:22 – 26.
47. Zugck C, Frankenstein L, Nelles M, Froehlich H, Schellberg D, Cebola R, 55. Dang S, Dimmick S, Kelkar G. Evaluating the evidence base for the use of home Remppis A, Katus HA. Telemedicine reduces hospitalisation rates in patients telehealth remote monitoring in elderly with heart failure. Telemed J E Health with chronic heart failure—results of the randomized HiTel trial (abstract). Eur 2009;15:783 – 796.
J Heart Fail Suppl 2008;7:9a.
48. Granger BB, Swedberg K, Ekman I, Granger CB, Olofsson B, McMurray JJ, Yusuf S, European Society of Cardiology Heart Failure Meeting 2010: TRIDENT 1, BEN- Michelson EL, Pfeffer MA, CHARM investigators. Adherence to candesartan and EFICIAL, CUPID, RFA-HF, MUSIC, DUEL, Handheld BNP, phrenic nerve stimu- placebo and outcomes in chronic heart failure in the CHARM programme: lation, CHAMPION and CABG with CRT study. Eur J Heart Fail 2010;12: double-blind, randomised, controlled clinical trial. Lancet 2005;366:2005 – 2011.
883 – 888.
49. Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, 57. Jones NA, Frankel DS, Piette JD, Goldberg LR. Withdrawal of a technology-based Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart daily weight monitoring system in patients with advanced heart failure eliminates failure. N Engl J Med 2010;363:2301 – 2309.
mortality benefit (abstract). Circulation 2007;116:3277.

Source: http://telehomecare.otn.ca/documents/10157/19426/HF+systematic+review.pdf?version=1.0

Chapter

Chemotherapy for Non-smal Cel Lung Cancer Marianne J. Davies, DNP, CNS-BC, ACNP-BC, AOCNP-BC and Amanda E. Reid, MSN, APRN, ANP-BC Introduction There are several treatment strategies available for non-small cell lung cancer (NSCLC). These include surgery, radiation therapy, chemotherapy, targeted therapy, immunotherapy, and palliative care. Patients may be treated with one type of treatment or a combination of treatments. This

alomone.com

Venom Peptides and their Mimetics as Potential DrugsOren Bogin, Ph.D. Venomous creatures have a sophisticated mechanism for prey capture which includes a vast array of biologically-active compounds, such as enzymes, proteins, peptides and small molecular weight compounds. These substances target an immense number of receptors and membrane proteins with high affinity, selectivity and potency, and can serve as potential drugs or scaffolds for drug design.