Abstract
There is a quote from Steven Johnson’s book, entitled How We Got to Now: Six Innovations That Made the Modern World, that states,
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Innovations usually begin life with an attempt to solve a specific problem, but once they get into circulation, they end up triggering other changes that would have been extremely difficult to predict.1,p3
This quote suggests the potential that sonographers have to develop new practice standards and identify causal relationships of disease and imaging findings, as well as how they have the potential through extension of their daily work to make change through contributing to research. An example of this is illustrated in the work of a sonographer, Pam Ruff, BS, RDCS, who noted in her daily work as a sonographer that patients who had a history of taking fenfluramine and phentermine (fen-phen) were presenting with a “peculiar” valvular pathology. 2
Fenfluramine and phentermine were individually approved anorectic agents by the Food and Drug Administration (FDA), and while not approved to be used in combination, in 1996, there were over 18 million prescriptions issued for the combination of these drugs to treat obesity.2,3 In 1997, Connolly et al. 2 reported that valvular disease may be associated with the use of the combination of these diet drugs. Connolly et al. 2 examined 24 cases (100% female, mean age [standard deviation] 44 [8] years of age treated with the combination of fen-phen for 12.3 [7.1] months, and all cases were from Minnesota and North Dakota). These individuals had not previously been diagnosed with cardiovascular disease other than systemic hypertension. 2 All 24 individuals presented with cardiovascular symptoms or a heart murmur and underwent echocardiography examination. All cases demonstrated a unique valvular pathology and regurgitation. Right- and left-sided valves were involved, and eight individuals had newly diagnosed pulmonary hypertension. Five patients out of the 24 required surgical intervention to treat their valvular disease. At histopathology examination, the heart valves demonstrated a “glistening white” appearance and were noted to have similar features to those seen with carcinoid or egotamine-induced cardiac valve disease. 2 Within two months of this initial report by Connolly et al., 2 the FDA received 144 case reports of valve disease in patients taking fen-phen or dexfenfluramine, and the drugs were voluntarily withdrawn from the market by the manufacturer. 3 Subsequently, additional imaging and follow-up of patients exposed to these diet drugs was undertaken to examine how valvular pathology was related to the incidence and prevalence of cardiac valvular pathology in individuals not exposed and exposed to fen-phen, as well as early progression and late progression of valvular disease and pulmonary hypertension after cessation of the anorectic drugs. 3 Ultimately, the initial report led to management and optimization of treatment for individuals exposed to these drug combinations.3,4
In the initial report by Connolly et al., 2 12 of the 24 cases were reported to have come from a physician employed at MeritCare Medical Center in Fargo, North Dakota. The physician had contacted the Mayo Clinic in Rochester, Minnesota, to see if there had been any reports regarding the use of diet medications and valvular heart disease. This inquiry was prompted by the physician due to keen observations by his cardiac sonographers who had noted that 12 patients had presented with a “peculiar” valve appearance, and all 12 had a history of taking fen-phen. 2 One sonographer in particular, Pam Ruff, BS, RDCS, was credited at the end of this initial report for identification of the patients. 2 In a follow-up letter to the editor in the New England Journal of Medicine, there is again mention that “twelve of the Fargo cases, and perhaps the association itself, were initially identified by an astute echocardiographic sonographer.” 5
Pam Ruff’s work is further credited in the book, entitled Dispensing With the Truth: The Victims, the Drug Companies, and the Dramatic Story Behind the Battle Over Fen-Phen, by Alicia Mundy. 6 In this book, Ms. Ruff’s work and intellectual curiosity are described, showing how she continuously collected information on patients who presented with a history of fen-phen use and valvular pathology to her cardiologists. The book also details how the physician reviewed this information with Dr. Connolly, who then authored the first paper describing not only an association with primary pulmonary hypertension but also valvular pathologies appearing in patients with a history of fen-phen use.
The powerful role that Pam Ruff played in linking the association between the use of fen-phen and the appearance of cardiac valvular pathology on the echocardiogram is pivotal in how this association led to a public safety advisory and eventual voluntary withdrawal of fenfluramine and dexfenfluramine from the market.3,6 Her attention to detail resulted in several future research studies to examine the relationship of these drugs with the incidence, prevalence, progression, and regression of cardiovascular disease associated with use and cessation of these drugs.2,4,7–9 Furthermore, her initial questions probably resulted in saving lives and optimizing medical treatment for many individuals. Ms. Ruff’s role also should motivate sonographers to engage in and seek opportunities to engage in clinical research.
Involvement in clinical research can lead to improved patient care, provide new methods for imaging and following treatment of disease, and identify new means for delivery of health care. In allied health professions (such as diagnostic medical sonography), there is a need to establish and promote evidence-based practice in the discipline.
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This requires members of the profession to engage in sonographer-led research to develop new knowledge specific to the discipline of acquiring ultrasound images, image processing, and methods for delivery of care through the use of diagnostic ultrasound imaging. One limitation that has existed for many sonographers to engage in their own formal research is educational preparation. Traditionally, allied health education programs have prepared individuals to practice their clinical specialty, with most programs preparing future practitioners at the certificate, associate, or baccalaureate degree level.
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While these educational programs are great at preparing individuals for entry into clinical practice, they do not necessarily prepare individuals for engaging in research, in which more knowledge is needed for theory-driven and scientifically grounded practice.
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One way for sonographers to engage in research is to seek advanced degrees at the doctorate level or to collaborate with physicians, basic scientists, and or other allied health professions who hold advanced degrees and have the educational preparation to assist with research design, analyses, and applying for external funding for sonographer research projects. Sonographers often have good ideas for innovative practice changes or new thoughts on how to recognize or diagnose a disease process, and they should feel empowered to share their ideas, find collaborators, and ask for help to follow up on a project. For just as the opening quote states, Innovations usually begin life with an attempt to solve a specific problem, but once they get into circulation, they end up triggering other changes that would have been extremely difficult to predict.1,p3
For who knows, you could be the next Pam Ruff and the next person to have a groundbreaking idea that will result in improved ways to acquire images, diagnose, or improve laboratory efficiency.