Synopsis/abstract

Synopsis/abstract

The EFICAR Study Protocol: A Synopsis Quality of life (QoL) is greatly considered in treating HF patients that, studies to improve this mark currentcardiology researches of which a significant finding is the efficacy of exercise. Though, the test of varied exercise programs using different QoL instruments showed conflicting effects, these did not negate the efficacy of exercise in improving QoL in HF patients. Thus this study aims “ to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors” (Zuazagoitia, et al., 2010, p. 1). Participants (600 HF patients – NYHA class II to IV), who went through 2 consecutive phases: “ therapy optimization,” and “ monitoring and evaluation of results” (p. 2-3), are centrally randomized to the EFICAR group (300) and the control group (300), in a multicenter clinical trial involving 6 primary health centers in Spain. Aside from the series of recommended best medication, health education and self-care development that both groups received, a progressive exercise program of “ high-intensity interval training” and “ muscular strength training” (p. 5) was added to the EFICAR group. Outcome was blindly measured thrice at 3, 6, and 12 months, using established relevant instruments. Study results affirm the efficacy of exercise in improving QoL, functional capacity and control of cardiovascular risk factors in 18-year old patients with stage 2-3 HF. Results of the study serve as evidence to persuade patients with HF to undergo the program. It can also aide in making guidelines as to how exercise could be optimized in improving QoL in patients with stage 2-3 HF. Deciding the Validity or Legitimacy of Evidence The usefulness of any evidence based researches lies on its validity and reliability. These two terms, according to Whitehead and McNiff (2006), although different are interrelated concepts where the former refers to the truthfulness of the claim, whereas the latter refers to the authority of the claimant to the knowledge (p. 97-98). As such, validity of evidence can be evaluated based on the research design used by which evidences are gathered: Its appropriateness (setting, population, intervention), reliability (research instruments, statistical tools, timeliness), and implementation. Thus findings of any evidence-based research must be based on the best or highest level of evidence available. Whereas, the legitimacy of the evidence depends on who conducted the research, on the selection of the relevant studies to back-up the claim, on the manner by which the evidence is gathered (ethics and legal laws). The bottom line in deciding the validity or legitimacy of evidence lies on its effectiveness, appropriateness and feasibility because without this three even how spectacular evidence may appear, it would remain useless. Meaning the evidence is truly useful, acceptable and implementable. Based on these considerations, Evans (2003) in his proposed hierarchy of evidence graded evidence gathered from systematic review and multi-center studies, excellent, and graded those gathered from RCT, observational studies, and interpretive studies, good (p. 79). The application of evidence on patient care, McGee (21020) reminds must take into full-consideration the particular condition of the patient in question, because each individual possesses different levels of pain, fear, uncertainty, tolerance, etc. that application of evidence cannot just be made in toto (par. 8). Furthermore, the patient’s consent must be respected. Nothing can supersede this. Abstract Several studies (Zuazagoitia, et al., 2010; Belardinelli, et al., 1999, & Dugmore, et al., 1999, cited in Andersen-Parrado, 1999) consistently show evidence that exercise is beneficial to HF patients from which they can derived maximum benefits such as improved QoL, functional capacity, cardiorespiratory fitness, and psychological wellbeing. However, the evidence is not generalized across ages. Since HF increasingly occurs at adult age (70-80) between 10-20% (Dickstein, et al., 2008, p. 2394), finding out the efficacy of exercise on HF adults patients is relevant that, this study is conducted. Aimed at evaluating how does exercise, with medication management vs. medication alone improve ejection fraction in adults with stage 2-3 HF, enrolled patient-participants, who qualified the set inclusion criteria are randomly grouped to the intervention group and control group in a multicenter, randomized, controlled clinical trial. Outcomes are blindly measured for reliability. Control procedures are installed to address the limitations of the study and maintain validity. Findings of the study support previous findings that exercise helps improve the physical condition and psychological wellbeing of adults with stage 2-3 HF, consequentially improving their functional capacity and allowing them to achieve improved QoL. References Dickstein, K., Cohen-Solal, A., Filippatos, G., McMurray, J. J. V., Ponikowski, P., Poole-Wilson, PA., Stro? mberg, A., Van Veldhuisen, D. J., Atar, D., Hoes, A. W., Keren, A., Mebazaa, A., Nieminen, M., Priori, S. G., & Swedberg, K. (2008). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008. European Heart Journal, 29: 2388-2442. doi: 10. 1093/eurheartj/ehn309 Evans, D. (2003). Hierarchy of evidence: A framework for ranking evidence evaluating healthcare interventions. Journal of Clinical Nursing, 12, 77-84. McGee, D. L. (2010). Evidence-based medicine and clinical guidelines. In Clinical decision making. Retrieved February 10, 2011, from http://www. merckmanuals. com/professional/sec22/ch328/ch328b. html Andersen-Parrado, P. (1999, June). Exercise – not just for healthy people. Benefits for those who least expect it, too. Better Nutrition, 61 (6), 24. Whitehead, J. & McNiff, J. (2006). Action research: Living theory. London, California, & New Delhi: SAGE. Zuazagoitia, A., Grandes, G., Torcal, J., Lekuona, I., Echevarria, P., Gomez, M. A., Domingo, M., De la Torre, M. M., Ramirez, J. I., M., Imanol, Oyanguren, J., Pinilla, R. O. S., & the EFICAR Group. (2010). Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care: The EFICAR study protocol. BMC Public Health, 10 (33), 1-10.