We appreciate the interest from our colleagues Civera et al. regarding the EFITIC trial.1 We believe, however, that some clarification is required:
The rationale for the study was the lack of adherence to dosage guidelines, as reflected in several articles, often associated with a lack of time rather than changes in the role of nurses.
ETIFIC was the first randomized multicenter trial1 that demonstrated the noninferiority of drug titration (dose adjustment) by heart failure (HF) nurses compared with HF cardiologists. The Cochrane review2 evaluated dose titration by HF nurses compared with primary care physicians.
The nurses in the ETIFIC trial had 400hours of HF training, 2 years of HF experience, and training in dose titration.
Dose titration is not the same as prescribing. ETIFIC established the initial individualized prescription by physicians, including the timing of dose adjustment as shown in figures 2-5 of the article on the study design.3 The nurses adjusted the dose following a very precise protocol, with predetermined autonomy and regular supervision from the cardiologist, but not at every visit (mean number of HF nurse appointments was 6.41±2.82 vs 2.20±1.21 with the cardiologist of the group).1
The protocol was agreed by cardiologists, nurses, and managers from 20 hospitals and 10 autonomous communities and was approved by 20 ethics committees and the Spanish Agency for Medicines and Medical Devices in 2014, when the law was more restrictive than now. Legal reform for dose titration is not necessary. The Law for the Regulation of Health Professionals 44/2003, of 21 November, preface explaining rationale, section II and Royal Decree 1302/2018, of 22 October, heading I, general provisions, establish the resolution of professional competencies through interprofessional agreement. In Spain, dose adjustment by HF nurses was a reality before the study and continues to be so.
The current legal framework, with the scientific support of ETIFIC, allows the option to titrate the dose safely and effectively as long as the conditions of the study are met: the nurses are trained, experienced, and have time, there is support from a cardiologist, screening for the procedure, and interprofessional agreement.
Ideally, quality indicators of the drug titration process would be determined by the Spanish Society of Cardiology or Spanish Association of Cardiology Nursing, whichever corresponds to the organization. From our perspective, the major benefits of optimizing drugs, confirmed in the ETIFIC trial (table 3 and Figure 4 of the study1), indicate that it is imperative that we adapt the process so that it is carried out in the safest possible way.
