Medical research in a changing world: research needs, opportunities, and imperatives in otolaryngology-head and neck surgery.
Completion of the Human Genome Project almost a decade ago introduced an important new dimension to biological and biomedical research and generated the broadest, most complex research opportunities in history. The overarching potential of this accomplishment is to transform the study of virtually all life processes. With it has come the prospect of understanding disease mechanisms at the molecular and cellular level, enabling the development of predictive, personalized treatment through the application of genomics and proteomics in a systems approach to disease.
Using technologies that enable isolation and identification of abnormal or diseased cells in individual patients, strategies for prevention, diagnostics, and therapeutics can be developed that are personalized and predictive of response to treatment. As each person's genotype is unique, the goal is to take advantage of genomic, proteomic, and metabolomic data to stratify subgroups of patients for similarly personalized, targeted treatments, moving away from empiricism. These are broad and long-range opportunities, already in the early stages of investigation, and will make their way into routine practical application over the next decade. Progress will be hastened by research from within individual specialties.
Other important research opportunities exist. For example, more than one-third-of adults and almost 20% of children in the United States are obese (National Health and Nutrition Examination Survey). While there are social, psychological, behavioral, and other factors that undoubtedly contribute to this condition, there is a wide-open opportunity to explore the roles of olfaction and gustation in eating behavior to gain further insight into the crisis in obesity, diet, and nutrition.
Work in several centers has established that gene products in saliva can serve as predictors of disease processes such as oral cancer. Opportunities still exist to evaluate which of those gene products are predictive and to use genotype analysis to guide personalized therapy choices for treatment. The use of viral vectors and nanoparticles as drug delivery systems is anticipated to play a larger role as the necessary technology and techniques are refined. This research will permit individualized therapies targeted to specific diseased cells without harm to surrounding healthy tissue. These extraordinary opportunities have generated their own unique needs and imperatives.
Opportunities offer the chance to gain an advantage, to make progress; when identified and acted upon at the right time, the rewards may be great. Needs, on the other hand, reflect necessities or obligations that arise from some situation. In our changing world, research is needed to understand the relationship between genomics and health disparities by evaluating the diverse contributions and interactions of socioeconomic status, health behaviors, culture, diet, environmental exposures, and genetics. As diseases are identified earlier and treated more effectively, acute, life-threatening diseases are becoming chronic; the classic example of this trend is AIDS. Here, the research challenge is to identify ways in which to achieve disease stability without sacrificing quality of life.
The specter of bioterrorism always accompanies the uneasy international relations that seem to be a fact of our modern world. Research into biodefense methods, and approaches to diagnosing and treating emerging infections, are top priorities. Many chemical and biological agents used in warfare are airborne and thus would affect the respiratory tract at an early stage, making this area of research particularly salient for otolaryngologists.
There is a need for trained clinician-researcher MDs and PhDs to bridge the gap between fundamental science and active care. After completing their research training, these individuals can initiate and support new directions for scientific discovery. In addition, they can organize and execute clinical trials and other forms of "real world" assessment of new therapies. Developing a cadre of translational researchers who are well prepared to collaborate with practicing clinicians, educators, and other healthcare professionals is an acute need. Addressing it will help to actualize the promise of new and emerging scientific developments in improving healthcare.
Will the Patient Protection and Affordable Care Act ("Obamacare") reach its full reality? Regardless of whether it's fully implemented, partially implemented, or repealed, medical decision making and reimbursement will be affected. Evidence-based medicine is here to stay. The imperative is for otolaryngologists to become more aggressive in generating high-quality evidence for the effectiveness of otolaryngologic interventions and their impact on health-related quality of life. An often-overlooked but quite important aspect of this imperative is the need for such evidence to be generated using data from a variety of practice settings to establish generalizability in a broad patient mix.
The Agency for Healthcare Research and Quality maintains the National Guideline Clearinghouse, a publicly available database of evidence-based clinical practice guidelines (www.guideline.gov/browse/ by-organization.aspx?alpha=A). Of the 2,343 published clinical practice guidelines, 7 were developed by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Others related to ORL diseases, disorders, and conditions have been developed by other specialty groups. In this case, the point is that an evidence-based guideline and its recommendations are based on best research evidence for the efficacy and safety of therapeutic, rehabilitative, and preventive measures, or for the accuracy of diagnostic tests or the power of prognostic markers. If there are options available and there is strong evidence for one and weak or absent evidence for another, the guideline will recognize the absence of evidence for the second option and recommend the former as being evidence based.
It is important to note that the absence of evidence does not mean the absence of efficacy or effectiveness; it means documentation gathered in a rigorous, systematic, uniform way is lacking, and documentation will be the key factor in distribution of healthcare re sources in the future. Thus, it is imperative to proceed with designing and implementing high-quality clinical studies to document the effectiveness of diagnostic and management procedures used in otolaryngology-head and neck surgery.
The therapeutic promise of genomics has ushered in an exciting new era that will drive the transformation of healthcare as it is practiced today to predictive, personalized, and more effectively preventive medicine. A crucial part of that journey must be to take all the necessary steps to ensure that the genetic tests and treatment options offered to the public have established clinical validity, usefulness, and safety. That is an imperative of the utmost importance.
Funding is essential to support research efforts. NIH funding is considered the gold standard, although obtaining it is quite a competitive and rigorous process. Nevertheless, there are more than 100 currently active NIH Program Announcements (PAs) and Requests for Applications (RFAs) to solicit research in conditions related to otolaryngology-head and neck cancer-ranging from spasmodic dysphonia to migraine to hearing impairment to sleep-disordered breathing, head and neck cancer, and olfaction. Other research funding is available through the AAO-HNS Foundation's Research Career Development Grants Awards and the Triological Society's Clinical Scientist Development Awards matching grant program with the American College of Surgeons.
In this second decade of the twenty-first century, research opportunities are many and varied as science and technology have defined powerful new tools. Research needs are shaped by demands of our changing world, society, and the need to prepare to meet the challenges ahead. Expert otolaryngologic research is imperative to protect both patients and the profession.
Maureen Hannley, PhD
American Auditory Society
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|Title Annotation:||GUEST EDITORIAL|
|Publication:||Ear, Nose and Throat Journal|
|Article Type:||Guest editorial|
|Date:||Sep 1, 2012|
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