Background
Focused cardiac ultrasound (FoCUS) is a simplified, clinician-performed application of echocardiography that is rapidly expanding in use, especially in emergency and critical care medicine. Performed by appropriately trained clinicians, typically not cardiologists, FoCUS ascertains the essential information needed in critical scenarios for time-sensitive clinical decision making. A need exists for quality evidence-based review and clinical recommendations on its use.
Methods
The World Interactive Network Focused on Critical UltraSound conducted an international, multispecialty, evidence-based, methodologically rigorous consensus process on FoCUS. Thirty-three experts from 16 countries were involved. A systematic multiple-database, double-track literature search (January 1980 to September 2013) was performed. The Grading of Recommendation, Assessment, Development and Evaluation method was used to determine the quality of available evidence and subsequent development of the recommendations. Evidence-based panel judgment and consensus was collected and analyzed by means of the RAND appropriateness method.
Results
During four conferences (in New Delhi, Milan, Boston, and Barcelona), 108 statements were elaborated and discussed. Face-to-face debates were held in two rounds using the modified Delphi technique. Disagreement occurred for 10 statements. Weak or conditional recommendations were made for two statements and strong or very strong recommendations for 96. These recommendations delineate the nature, applications, technique, potential benefits, clinical integration, education, and certification principles for FoCUS, both for adults and pediatric patients.
Conclusions
This document presents the results of the first International Conference on FoCUS. For the first time, evidence-based clinical recommendations comprehensively address this branch of point-of-care ultrasound, providing a framework for FoCUS to standardize its application in different clinical settings around the world.
The history of echocardiography began with the collaboration of Drs. Edler and Hertz in Lund in 1954. It has since evolved into a highly sophisticated and powerful tool. Comprehensive standard echocardiography provides information on virtually all aspects of heart morphology and function, disclosing numerous derangements in cardiovascular physiology. However, image acquisition and interpretation of comprehensive standard echocardiography require extensive training. Until recently, this technology was provided only to stable patients able to reach an echocardiography laboratory.
With the advent of mobile, portable, and pocket-sized ultrasound machines, this imaging modality is now readily available in emergency and critical care settings in time-sensitive scenarios in which it is immediately needed. Ease of use, availability of diagnostic information within a short time, high-quality imaging in most patients, and low complication rates have led to the widespread use of echocardiography in the perioperative, critical care, and emergency medicine environments. For many years, the scientific community has affirmed that ultrasound imaging is within the scope of practice of multiple medical specialties Indeed, American Medical Association Resolution 802 states that “the privileging…training and education standard [be] developed by each physician’s respective specialty.”
In these settings, realizing the benefit of echocardiography in the management of critically ill or injured patients, a different, simplified, clinician-performed application of this technology has also been developed: focused cardiac ultrasound (FoCUS). This sonographic evaluation of the heart is limited in comparison with comprehensive standard echocardiography, and it is conducted by appropriately trained clinicians, typically not cardiologists, to ascertain only the essential information needed in critical scenarios and time-sensitive decision making. Generally, a FoCUS examination is brief and addresses a few clinical questions, mainly in a dichotomous (yes or no) fashion (e.g. “Is the patient hypotensive because of severe dysfunction of the left ventricle or not?” “Is the cause of shock cardiac tamponade or not?”).
Interestingly, FoCUS was derived for nonechocardiography specialists for two different reasons, two journeys that coalesced at the same end point:
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Emergency, critical care, and prehospital physicians have been eager to expand the use of smaller and portable ultrasound equipment in critical settings, where the modality has been underused, and thus developed focused scanning protocols, which can be mastered by practitioners with appropriate training.
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Simultaneously, cardiologists have urged other specialists to decrease the inappropriate use of comprehensive standard echocardiography for mere screening purposes for cardiac pathology in specific populations and mostly in asymptomatic high-risk patients. To attain these goals, limited scanning protocols for practitioners with focused training have been proposed.
These groups of physicians have ended up at the same point: FoCUS.
Several scientific bodies have previously provided guidelines and recommendations for comprehensive standard echocardiography, critical care echocardiography, and a few on emergency echocardiography. Labovitz et al . published jointly with the American College of Emergency Physicians and the American Society of Echocardiography (ASE) a consensus statement on FoCUS in emergency medicine. Spencer et al . produced an expert consensus statement for the ASE in 2013.
The use of clinician-performed ultrasound is specialty specific. The specialists using this technology have the responsibility to determine the training, imaging criteria, accreditation of training programs, and quality management of the use of FoCUS. A need exists for quality evidence-based review and clinical recommendations. Therefore, the World Interactive Network Focused on Critical UltraSound (WINFOCUS) conducted an international, multispecialty, evidence-based, and methodologically rigorous consensus conference on FoCUS. The recommendations that follow represent a framework for FoCUS intended to standardize its application around the world and in different settings.
Methods
Recommendation-Building Methodology
The evidence-based statements and recommendations presented in this document were developed using a rigorous methodologic regimen, previously described, starting with the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) method. This approach entails: (1) a preliminary determination of the quality of available evidence and (2) the subsequent development of the recommendations. All articles concerning the conference object were ranked into three levels of quality according to the GRADE methodology for guideline and recommendation development ( Table 1 ). Second, evidence-based panel judgment and consensus were collected by means of the RAND appropriateness method, which incorporates a modified Delphi technique carried out in a minimum two face-to-face rounds of debate and voting. The RAND appropriateness method was also applied to formulate recommendations based exclusively on expert consensus, such as the ones concerning terminology. On the basis of the GRADE criteria, recommendations were generated in two classes (strong and weak or conditional), according to preset rules defining the panel’s agreement and consensus and its degree, as illustrated in Figure 2 of Appendix 1 in the Electronic Supplementary Material (ESM). That in turn determined the wording of each recommendation. Phrasing of strong recommendations used “we recommend” (or the verb “must” or “should”), while weak or conditional recommendations used “we suggest” (or the verb “may”), as shown in Table 4 of Appendix 1 in the ESM. Implications deriving from the strength of recommendations are illustrated in Tables 5 and 9 of Appendix 1 in the ESM. The conversion of evidence into recommendation depends on its evaluation by the panel as concerns quality of evidence, outcome importance, benefit/burden and benefit/harm balance, and finally the degree of certainty about similarity in the values and preferences of average patients, as applicable. Final grading of recommendations, on the basis of their strength and on level of evidence, is described in Table 2 . A detailed description of the GRADE and RAND appropriateness methodology used, as already published, is provided in Appendix 1 in the ESM. The clinical practice guidelines development process that we followed aimed at fulfilling the 2011 Institute of Medicine of the National Academies report of the eight standards for trustworthy guidelines. Great attention was paid to meet these standards, to overcome the shortcomings of similar guidelines previously published in this field. Because some of them did not meet more than a small portion of these standards, these guidelines created controversies and received variable degrees of acceptance and therefore had limited applicability. We believe that the more guidelines are robust in methodology, by meeting these eight standards, the greater will be the chance for them to be universally accepted and hence widely applied.
