Practice-Based Research Networks and Their Impact on Dentistry: Creating a Pathway for Change in the Profession
Frederick A. Curro, DMD, PhD; Ronald G. Craig, DMD, PhD; Van P. Thompson, DDS, PhD
In his July/August 2008 Compendium article entitled The Lessons of History on Charting a New Pathway for Acceptance of Innovations,1 Edward F. Rossomando, DDS, PhD, MS, observes that the dental profession is at an impasse. He notes that typically an innovation in dental practice “migrates from the manufacturer, then finds acceptance in dental offices if endorsed by the dentist (and accepted by patients), and finally is added to the clinical curriculum”—a process that is becoming progressively more inefficient as the latest generations of treatments, materials, and devices reach the dental marketplace. “The soon-to-be-introduced bio-based innovations may require the development of an alternative pathway,” Rossomando writes. The pathway he proposes involves the establishment of specialized academic centers where faculty, in collaboration with the dental industry, can train students in new technologies. We wish to propose an additional solution.
It is estimated that more than 70% of US dentists are engaged in private practice.2 Thus, dentistry can essentially be viewed as a cottage industry in which a relatively small percentage of dentists are associated with hospitals or universities. Most dentists practice far from academic centers and commonly receive information on scientific and clinical advances from peers, through testimonials, and by “What Works in My Office” presentations at trade and dental conventions. Therefore, dental practice suffers from the absence of a formal pathway for establishing and implementing a base of clinical data such as what exists in medicine. For example, through the Food and Drug Administration (FDA), medicine employs a formal process of product approval in the pharmaceutical industry. This difference between medicine and dentistry is mostly a result of return on investment. Corporate investment in a new medical drug or device can support a series of FDA-monitored clinical trials and still return large profits. However, even in medicine, a substantial lag time occurs between initial research findings and the entry of a new drug, device, or therapy into the marketplace—by one account, an average of 17 years.3 At least in medicine, an educational pathway exists—absent in dentistry—that helps practitioners learn from a consensus of data.
The practice of dentistry primarily involves a process of codified treatment procedures: a process based on and reinforced by the reimbursement process. The profession also is highly dependent upon materials and devices. In recent years, dentistry has had an increased use of drugs for both patient management and treatment, including the development of so-called drug devices, particularly in the treatment of periodontal disease. Pharmaceutical companies and device manufacturers, however, have not typically viewed dentistry as a market for product development. The current mode of advancement for a drug for use in dentistry is by conducting studies for additional labeling of drugs already approved for medical use.
As our knowledge of the basic biology of the teeth and surrounding structures increases, advances in diagnostics and therapeutics will be made based on biotechnologies. What is needed is a cost-effective pathway for pharmaceutical companies and dental device and materials manufacturers to introduce new products to the profession based on clinical data. Ideally, this pathway will include private practitioners as well as academic centers that eventually will influence dental school curricula.
Such a pathway was recently created by the National Institute of Dental and Craniofacial Research (NIDCR) in the form of dental practice-based research networks (PBRNs). PBRNs, a concept from the late 1970s, are typically associations of practitioners who have common interests and conduct studies that are minimally funded on an ad hoc basis. The novelty of the new dental PBRNs is the NIDCR’s commitment in funding for a 7-year period to ensure sustainability in an effort to move the profession forward by raising the level and extent of clinical studies. The authors’ PBRN, PEARL (Practitioners Engaged in Applied Research and Learning), is one of three PBRNs funded by NIDCR. PEARL represents the northeast US, with administrative functions based at New York University (NYU) College of Dentistry and study data coordination and analysis at The EMMES Corporation® (Rockville, MD). The two other NIDCR-funded PBRNs, DPBRN (Dental Practice-Based Research Network) and Northwest PRECEDENT (Practice-based REsearch Collaborative in Evidence-based DENTistry), represent the southeast and northwest US, respectively.
Studies by the NIDCR-funded PBRNs are typically standard-of-care, effectiveness, or best-practice investigations; in addition, PEARL has begun a randomized, controlled clinical trial. Effectiveness research evaluates the clinical setting as well as the healthcare system on which it depends.4 PEARL research typically includes patient-reported outcomes that give studies a balance of information from both the practitioner-investigator and the study participant. Depending upon the study, dental PBRNs can use the power of a large number of practitioner-investigators each recruiting a small number of patients; this is in contrast to a standard clinical trial in which a few investigators recruit a large patient population. PBRN studies also differ in that they generate real-time, real chairside data, varied in use by large numbers of practitioners to demonstrate robustness, in a high number of patients to uncover any negative aspects. Randomized controlled studies are often criticized for using targeted populations.
Dental PBRNs also can be positioned to conduct Phase IV surveillance or drug safety studies. Although creation of a drug or device clinical study pathway was not part of NIDCR’s mandate for establishing PBRNs, it is a natural extension of mature networks and can, in fact, help augment government support for these networks. In a PBRN, practitioner-investigators are connected to an academic hub and trained to conduct clinical research in their offices with minimal disruption to their office routine. PBRN practitioner-investigators are trained in Good Clinical Practices (GCP) so that studies can be audited with a proper level of quality assurance. PEARL studies are subject to the same rigorous oversight as those involving a drug being tested for FDA approval. Thus, dental PBRNs have the potential to create new markets for drug and device companies, which in turn will be able to invest in more products serving the profession.
More central to the issue of establishing a pathway for introducing innovations into dentistry, the PBRN provides for the first time a mechanism for general practitioners to participate in clinical studies. It is generally recognized that most research evidence currently generated does not reflect the settings where most clinical care is provided.5 Academic or hospital-based research is more common than research in primary care, and there is resistance to generalizing research findings because of possible differences in the population groups and clinical environment.6 The results of PBRN studies have the potential to hasten the incorporation of change into the profession because the data are generated in actual private practice settings. This new mechanism for producing “real participatory data” can have a profound effect on the future of dentistry as well as providing pharmaceutical companies and dental-device manufacturers with a means of introducing innovative bio-based products to the profession in a way that clinicians can accept and use in their practices. Because PBRNs are based at schools of dentistry, network practitioner-investigators can remain more up-to-date with innovations and provide feedback on how fellow network members are practicing, making dentists less isolated. One difference between medicine and dentistry is that physicians constantly have some form of oversight. Most dental practices have virtually no oversight, and dental records are rarely the object of third-party review. One advantage of PBRN training is that it imposes a level of standardization in dental recordkeeping, which is as important in practice as it is in research. The steps in creating a treatment plan parallel those of a research protocol. In medicine, primary care practice-based research networks are challenging traditional distinctions between research and quality improvement, emphasizing the importance of linking discovery and application, research, and practice. These networks are finding that less translation is required to apply research to practice when clinicians are involved in deciding what to study, how to study it, and how to evaluate and present the results.7
Publication of data generated by PBRN practitioner-investigators creates a pathway of information that can send feedback to the dental school curriculum. PEARL’s Information Dissemination Core aims not only to oversee the peer-reviewed publication of study results that have the potential to change dentistry but also to present results to NYU and other dental institutions in the hope that the lessons learned from the results of clinical studies will be incorporated into the undergraduate curriculum. Another potential benefit of dental PBRNs is the training that network practitioners receive in clinical research. This base of clinical research-trained dentists may help fill the increasing number of vacant faculty positions in dental schools throughout the US.
The PBRN bio-based innovations pathway will help change the way dental schools train future dentists and how current practitioners provide dental care. It is anticipated that the PBRN pathway will facilitate a shift from the current procedural-based approach to dental care to one that incorporates a knowledge-based model similar to that employed in medicine in which diagnosis, prevention, and disease control comprise a major focus. If the experiment is successful, the dental PBRN concept can afford dentistry an opportunity for change, to broaden its professional responsibilities, and to identify its proper place in the nation’s future healthcare program.
References
1. Rossomando EF. The lessons of history on charting a new pathway for acceptance of innovations. Compend Contin Educ Dent. 2008;29(6):364-368.
2. Employment situation of dentists in private practice. ADA Survey Center. ADA News. 2007;38(14):1.
3. Balas EA, Boren SA. Managing clinical knowledge for health care improvement. In: Yearbook of Medical Informatics 2000: Patient-Centered Systems. Stuttgart, Germany: Schattauer; 2000:65-70.
4. Kupersmith J, Sung N, Genel M, et al. Creating a new structure for research on health care effectiveness. J Investig Med. 2005;53(2):67-72.
5. Clarkson JE. Getting research into clinical practice—barriers and solutions. Caries Res. 2004;38(3):321-324.
6. McGlone P, Watt R, Sheiham A. Evidence-based dentistry: an overview of the challenges in changing professional practice. Br Dent J. 2001;190(12):636-639.
7. Mold JW, Peterson KA. Primary care practice-based research networks: working at the interface between research and quality improvement. Ann Fam Med. 2005; 3(suppl 1):S12-S20.
About the Authors
Frederick A. Curro, DMD, PhD PEARL Executive Management Team
Director
Regulatory Affairs and Clinical Investigations
Bluestone Center for Clinical Research
New York City College of Dentistry
New York, New York
Ronald G. Craig, DMD, PhD
PEARL Executive Management Team
Associate Professor
Department of Basic Sciences and Craniofacial Biology
Department of Periodontology and Implant Dentistry
New York City College of Dentistry
New York, New York
Van P. Thompson, DDS, PhD
PEARL Executive Management Team
Chair of Biomaterials and Biomimetics
New York City College of Dentistry
New York, New York
