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Rapid Responses: Rapid Responses published:
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Fantastic for heart failure…. but how does it work?
- Dr Gerard J Molloy (19 August 2005)
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Are calculations correct ?
- murad ruf, murad ruf (21 August 2005)
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Close the clinics and cancel home visits in heart failure management? What do the results of the DIAL Trial really tell us?
- Robyn Clark, Prof Simon Stewart (23 August 2005)
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What is the DIAL trial?
- Tsung O. Cheng (30 August 2005)
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Re: Are calculations correct ?
- Daniel C Ferrante, Hugo Grancelli, Daniel Nul, Sergio Varini, Saul Soifer, Hernán Doval (11 October 2005)
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Re: What is the DIAL trial?
- Hugo O Grancelli, Daniel Nul, Sergio Varini, Saul Soifer, Daniel Ferrante, Hernán Doval (11 October 2005)
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Re: Close the clinics and cancel home visits in heart failure management? What do the results of the DIAL Trial really tell us?
- Hugo O Grancelli, Daniel Nul, Sergio Varini, Saul Soifer, Daniel Ferrante, Hernán C. Doval, for GESICA Investigators. (19 October 2005)
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Dr Gerard J Molloy, Research Fellow School of Psychology, William Guild Building, University of Aberdeen, Aberdeen AB24 2UB
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There is now little doubt that multidisciplinary management programmes in post admission patients with heart failure have clear health benefits for patients and savings for the health care system [1]. The impressively powered DIAL trail reported by the Gesica Investigators [2] adds further weight to this contention and suggests that a ‘low dose of treatment’ in the form of a centralised telephone service may achieve the desired effect. However this line of research for the most part has failed to address a fundamental question. How does it work? A central aim of the DIAL trial and many similar interventions is to change the behaviour of heart failure patients. In particular, adherence to medical regimens, self-monitoring and seeking medical attention are thought to be key behavioural targets for change. However given the heterogeneity of these interventions it is only possible to offer tentative suggestions about how these behaviour change interventions work. There has been for some time now considerable progress theoretically and empirically in understanding the mechanisms behind health related behaviour change [3]. However DIAL and other similar studies show little evidence that this body of work has informed the development of their interventions. The main advantage of a theory based approach to behaviour change is that it allows researchers to causally model the mechanisms behind behaviour change and behaviour changes consequent influences on health outcomes. A causal modelling approach to health behaviour change has recently been comprehensively described [4]. This approach has the potential to set investigators along a path, which ultimately aims to answer that ever elusive question for successful complex interventions that aim to change patient behaviour. How does it work? Reference List 1. Phillips CO, Wright SM, Kern DE, Singa RM, Shepperd S, Rubin HR. Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure - a Meta-Analysis. JAMA 2004; 291(11):1358-67. 2. Geisca Investigators. Randomised trial of telephone intervention in chronic heart failure: DIAL trial. BMJ 2005; 331:425 3. Bandura A. Health promotion by social cognitive means. Health Education and Behavior 2004; 31(2):143-64. 4. Hardeman W, Sutton S, Griffin S et al. A causal modelling approach to the development of theory-based behaviour change programmes for trial evaluation. Health Education Research 2005; Mar 21; [Epub ahead of print] Competing interests: None declared |
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murad ruf, SpR Public Health lewisham pct se12 8rn, murad ruf
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Dear Sirs, The results of table 2 in BMJ.com (table in BMJ edition) for events of the primary endpoint are given as 200(26.3%)of 760 in the intervention group and 235(31%) of 758 in the control group. The relative risk is reported as 0.80 (0.66-0.97). However, when the relative risk is calculated using these values the RR=EER/CER= 26.3/31=0.8484. Calculating the RRR=(CER-EER)/CER)= (31- 26.3)/31=0.1516 or 15%, not 20% as reported in the paper. Similarly the RRs and RRRs for the other outcomes given in the paper were different (except for All cause mortality). I did not calcultate confidence intervals to assess whether results would still be statistically significant but it appears the presented results would overestimate the effect of the intervention. I would appreciate if you could clarify the apperant discrepancies. Regards M. Ruf Competing interests: None declared |
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Robyn Clark, PhD Scholar supported by the National Institute of Clinical Studies & National Heart Foundation University of South Australia 5000, Prof Simon Stewart
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Dear Editor
The recently published DIAL trial [1] is a welcome addition to the increasing number of studies demonstrating the benefits of applying dedicated chronic heart failure (HF) management programs. [2] In the first multi-centre randomised trial including more than 1500 patients followed for more than a year, the GESICA Investigators demonstrated that a simple and effective telephone intervention applied by highly trained nurses resulted in a significant reduction in HF admissions. A key question, of course, is how can we interpret the results of the DIAL trial relative to other popular forms of HF management? Should we accept the author’s assertions that "…Although multidisciplinary and complex strategies could provide greater advantage, the results of our simple intervention were still similar to those of other reported combined strategies. In fact our intervention would be justified as it is equally effective at a reasonably lower cost" 1 There are a number of reasons why a careful analysis of the literature particularly based on a recent systematic review and meta-analysis of more than 29 randomised studies of HF management, [2] would draw different conclusions from that outlined above. Although the DIAL trial undoubtedly recruited a younger (mean age 65 compared to 72 years) and probably more stable HF patients that included a greater preponderance of men (71% versus an average of 55%), it is worth comparing the results of this study with that of the 29 studies included in the aforementioned meta-analysis. As such, the table below clearly shows that the absolute impact of the telephonic intervention tested in the DIAL trial, while being largely consistent with other studies of telephonic support in HF, is clearly inferior to "multidisciplinary and complex strategies" on health outcomes: particularly when considering their combined impact on all-cause mortality (RR 0.75, 95% CI 0.59 to 0.96) and all-cause hospitalisation (RR 0.81, 95% CI 0.71 to 0.92).2 Clearly, telephonic interventions do have a positive impact on HF-related admissions. However, as demonstrated by the data presented in Table 1, its overall impact on all-cause events is less impressive than more complex programs of care: undoubtedly because the syndrome of HF is associated with a range of co morbidities that also require management and substantially contribute to morbidity/mortality. In terms of cost-effectiveness of these programs, it has been clearly demonstrated that the majority of HF-related costs are attributable to recurrent hospital stay. [3] The last column of Table 1 shows that both clinic and community-based, multidisciplinary programs of care have a more substantive impact on recurrent hospital stay (range 39 to 61%) than telephone-based programs overall; these data were not presented for the DIAL trial. It is on this basis that multidisciplinary programs of care should be applied whenever possible to both reduce costs and improve individual health outcomes.[3] Is there a role, therefore, for telephonic management in heart failure? Overall, a careful analysis of the DIAL trial shows that its results are largely consistent (if not more positive) with previous studies of its type. Based on this impressive study, there is obvious merit in managing patients with HF who have access to a telephone but limited access to specialist HF care (i.e. those living in rural and remote regions). However, there is no reason to suggest (at this stage) that clinics should be closed and home visits cancelled in favour of phone calls to HF patients in order to prolong survival and reduce recurrent hospital admissions in a cost-effective manner. References 1. GESICA Investigators. Randomised trial of telephone intervention in chronic heart: DIAL Trial. BMJ, Doi:10.1136/bmj.38516.398067.EO. (Published 1 August 2005) 2005. 2. McAlister FA, Stewart S, Ferrua J, McMurray JJV. Multidisciplinary strategies for the management of heart failure patients a high risk admission: a systematic review of randomised trials. J Am Coll Cardiol. 2004; 44(4). 3. Stewart S. Financial aspects of heart failure programs of care. Eur J Heart Fail. Mar 16 2005; 7(3):423-428.
Table 1 Comparison of absolute and relative effect of different forms of HF management: comparison to DIAL trial results *
Adapted from McAlister [2] and Stewart [3]. F/U = months. RR = Relative Risk. CI = Confidence Interval Competing interests: None declared |
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Tsung O. Cheng, Professor of Medicine George Washington University, Washington, DC 20037
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After reading over and over the DIAL trial reported by the GESICA Investigators [1] in an attempt to find out what the acronym DIAL stood for, I finally gave up. The authors never explained what the acronym DIAL stood for, although they did define the other acronym GESICA in the footnote. One of the “Uniform Requirements for Manuscripts Submitted to Biomedical Journals” published by the International Committee of Medical Journal Editors [2] is that every abbreviation or acronym should be explained when first used. To use unexplained acronyms in any scientific publication causes reader frustration [3] and aggravation [4]. This is the reason why physicians and other healthcare professionals hate to read medical journals, especially specialty journals, nowadays [5,6]. I think that cardiologists, of which I am one, are the most guilty group of physicians who frequently use unexplained acronyms [7]. They often take for granted that these trial acronyms are “trade terms” and do not bother to define them [8]. The old and frequently quoted argument, “everybody knows what that stands for”, is no longer true in the modern era of super-specialization [9]. I would be interested in knowing, if you would take a poll from your readers of this particular issue of the journal, what percentage of them would know what the acronym DIAL stands for. I, of course, suspect that the authors invented the acronym DIAL, because the trial was about the use of telephone. Now I only wish I know what DIAL stands for. Tsung O. Cheng, M.D.
References 1. GESICA Investigators: Randomized trial of telephone intervention in chronic heart failure: DIAL trial. BMJ 2005;331:425-427. 2. International Committee of Medical Journal Editors: Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med 1997;336:309-315. 3. Cheng TO: Unexplained acronyms. Circulation 1999;99:1924-1925. 4. Cheng TO: Acronym aggravation. Br Heart J 1994;71:107-109. 5. Cheng TO: Use of unexplained acronyms in specialty journals. Int J Cardiol 1994;46:185-188. 6. Cheng TO: Acronymophilia: The exponential growth of the use of acronyms should be resisted. Br Med J 1994;309:683-684. 7. Cheng TO: Acronyms of clinical trials in cardiology – 1998. Am Heart J 1999;137:726-765. 8. Cheng TO: Should we ENACT laws against gambling in RENO? Eur Heart J 2003;24:1700. 9. Cheng TO, Julian D: Acronyms of cardiologic trials – 2002. Int J Cardiol 2003;91:261-351. Competing interests: None declared |
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Daniel C Ferrante, Investigator GESICA Foundation, Hugo Grancelli, Daniel Nul, Sergio Varini, Saul Soifer, Hernán Doval
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Dear Sirs: Our calculations of relative risks are indeed rate ratios obtained by dividing two incidence densities, not cumulative incidences. This type of calculation is always done when patients are not followed the same length of time. (i.e the majority of large scale clinical trials). For example, for our primary end point, 200 primary events were observed in 342057 patients-day of observation in the intervention group (aprox 950 patients-year) and 235 events were observed in 324692 patients-day (aprox 901 patients-year)in the control group. The incidence densities in each group were 21 events per 100 patients-year in intervention vs. 26 events per 100 patients-year in the control group, yielding a RR of 0.80. The same case is for all end points evaluated and for multivariable analyses, which were performed using time to event survival analyses. Database and statistical output are available for consultation. Best regards
Competing interests: None declared |
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Hugo O Grancelli, Investigator GESICA Foundation, Daniel Nul, Sergio Varini, Saul Soifer, Daniel Ferrante, Hernán Doval
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Dear Sirs: DIAL Trial stands for: Ran"D"omised trial of telephone "I"ntervention in chronic he"A"rt fai"L"ure. The upper case letters were included in the Introduction and were lost during the submitting process. Best regards Hugo O Grancelli
Competing interests: None declared |
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Hugo O Grancelli, Investigator Rivadavia 2358 (1034) Buenos Aires ARgentina, Daniel Nul, Sergio Varini, Saul Soifer, Daniel Ferrante, Hernán C. Doval, for GESICA Investigators.
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DIAL trial results: Strength of evidence in heart failure programmes. Grancelli Hugo, Nul Daniel, Varini Sergio, Soifer Saul, Ferrante Daniel, Hernán Doval, for GESICA Investigators. GESICA Foundation, Buenos Aires, Argentina. The evidence of the effect of heart failure programs comes from metanalysis of small studies, so the benefit of these interventions might not be conclusive, since the majority of the studies were from single centers, with short follow-up, methodological limitations, and low standardization of interventions. In McAlister`s metanalysis (1), a study of only 20 patients is included, and in Whellan`s metanalysis (2), 15 of the 19 studies were from single centers. DIAL trial should not be considered an addition to previous evidence. It is a study including 51 centers, 1518 patients, optimal current therapy, homogeneous telephone intervention (based on education, monitoring and self-care skills) as the single strategy, with blinded evaluation of end points by and independent event committee. The conclusion that telephone interventions are clearly inferior to multidisciplinary interventions might be misleading. The classification of the studies in different mataanalysis is rather arbitrary, since the same study can be found in different categories, for example Krumholz et al study is classified as telephonic by Whellam and Phillips (3), and non- telephonic by McAlister. Moreover, it might not be valid to assume superiority of one strategy, using results from different studies, where patients and clinical settings are so different – ambulatory care vs. post discharge, optimal vs. non- optimal drug therapy, etc. The effect estimated in Clark’s et al letter is not in agreement with our reported results, since they did not use time to event analysis. Well designed large scale clinical trials provide the kind of evidence that is not obtained with metaanalysis of small studies, since these reviews are prone to methodological problems and publications biases of original studies. The only way to determine if one intervention is superior to another one would be to design and conduct a large scale randomized clinical trial, even larger than DIAL trial, comparing different strategies or their combination. 1- McAlister FA, Stewart S, Ferrua S, McMurray JJ. Multidisciplinary strategies for the management of heart failure patients at high risk for admission: a systematic review of randomized trials. J Am Coll Cardiol. 2004 ;44(4):810-9. 2- Whellan DJ, Hasselblad V, Peterson E, O'Connor CM, Schulman KA. Metaanalysis and review of heart failure disease management randomized controlled clinical trials. Am Heart J. 2005;149(4):722-9 3- Phillips CO, Wright SM, Kern DE, Singa RM, Shepperd S, Rubin HR. Comprehensive discharge planning with postdischarge support for older patients with congestive heart failure: a meta-analysis. JAMA. 2004 Mar 17;291(11):1358-67. Competing interests: None declared |
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