Author + information
- Daniel Ferrante, MD, MSc* (, )
- Hugo Grancelli, MD,
- Alejandro Macchia, MD,
- Sergio Varini, MD,
- Daniel Nul, MD and
- Hernan Doval, MD
- ↵*GESICA Foundation, Rivadavia 2358 1ro 4, Buenos Aires 1034, Argentina
Recently, Clark et al. (1) reviewed what they considered all available evidence on the effectiveness of disease management trials in heart failure, concluding that the evidence thus far lacks methodological quality. They particularly emphasized the poor quality of reports and design methods suggested by the Consolidated Standards of Reporting Trials statement.
We fully agree with the importance of following such rules, not only during the reporting and writing phase but also during the design and implementation of clinical trials.
For this reason, we were surprised by the omission of the DIAL (Randomized Trial of Telephone Intervention in Chronic Heart Failure) (2) from the investigators' discussion. DIAL was the largest and among the best designed and implemented trials in this area. The trial tested the effectiveness of a very applicable telephone-based intervention, including more than 50 centers and 1,500 patients, which reduced heart failure admissions by 30% (3). In contrast, most trials in this area have included patients from single centers, in academic environments, implementing complex programs, and in general they have not obtained similar results. Furthermore, DIAL was designed and reported according to Consolidated Standards of Reporting Trials guidelines; its report in the British Medical Journalfulfilled all aspects required by the statement, including a clearly defined intervention, a comparator or intervention in control group, measurement of events, a clearly defined population, clear statements about the therapies and intensity of care in the control group, a flow chart of participants, and clearly stated objectives, end points, statistical analyses, and results.
DIAL was also an independent clinical trial and was conducted in Argentina. Although we believe that these characteristics could make DIAL's results less applicable for reviewers in developed countries, we would like to suggest that Clark et al. (1) discuss all available evidence on the topic to both avoid bias and help physicians make appropriate decisions about the appropriateness and effectiveness of disease management programs in heart failure.
- American College of Cardiology Foundation