ADHA Access March 2012 : Page 19

Integrating Research into Clinical Practice By Jan Carlton Holland, RDH, MS; Muna Anabtawi, DDS; Sonia Makhija, DDS, MPH; Kimberly A. Funkhouser, BS; and Debbie Robinson, CDA, MS Introduction hroughout one’s career, there can be a desire for new challenges, independence, new direction and a new focus while remaining within the scope of a profession. Incorporat-ing clinical research into a professional routine, whether it’s within a private practice or an educational environment, is a new direction that is becoming increasingly more attrac-tive and can be a natural transition for the practicing dental hygienist and dental team. This paper is the result of the information acquired from a team of dental practitioners who were brought together to prepare and conduct a National Institute of Dental and Craniofacial Research (NIDCR) funded, three-year, multi-center, randomized, placebo-controlled, double-blind study to determine the effectiveness of xylitol mints in reducing the incidence of coronal and root caries in caries-active adults. The authors hope to provide insight into the skills, processes and challenges involved in integrating research into a clinical environment, and what can be learned to help the reader prepare for a possible new direction within their profession. a mentor in this area of concentration were essential factors for integrating clinical research into their profession. 8 Layher discusses the importance in preparing for a study, and the signi ¿ cance of organizing all aspects of the study. Mentor-ing from the site investigator and/or the sponsoring research organization can assist with the preparation and day-to-day operations of a clinical research study. 9  T With studies developed by private practitioners and conducted in the private practice setting, results become more relevant to clinicians and lead to improved and applicable clinical treatment in a shorter amount of time. } Common Components and Characteristics of Practice-Based Research Projects Because each clinical study varies by its subject mat-ter, funding resource, enrollment size, target population and study design, there is not a standard instruction manual for a dental team to follow from start-up to conclusion. The major-ity of dental practices that have integrated research into their daily job responsibilities receive on-the-job training, with the preparation and actual conducting of the study from either dental faculty or research professionals who have the knowl-edge base and skills to conduct dental research. The research team is composed of clinical and nonclini-cal personnel with varied backgrounds and experience. Each person involved will take on speci ¿ c roles. The principal investigator (PI) oversees the research study from conceptu-alizing and writing the grant proposal through study closure, and makes the ¿ nal decisions for their speci ¿ c site; the study coordinator (SC) is the day-to-day manager of the study. The majority of the job activities for a study tend to fall under the responsibility of the study coordinator; the examiner (E) can be the dentist or dental hygienist, depending on the study. This person is trained and calibrated to evaluate aspects of relevant study variables such as dental decay, periodontal disease, or in the application of study medications or dental materials. The recorder (R) works with the examiner in re-cording and documenting treatment. Other study staff roles may be speci ¿ c to a study or to a site (See Table I). Each person involved in the clinical research requires training prior to and throughout the study to comply with federal regulations and research guidelines for the protection of human subjects and to ensure the quality of the data is protected. 10 This training includes: Health Insurance Portabil-ity and Accountability Act (HIPAA) for con ¿ dentiality require-ments; Good Clinical Practice (GCP) guidelines in accordance with the U.S. Food and Drug Administration Code of Federal Guidelines; and the Protection of Human Subjects training is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical studies. The goals of GCP guidelines are to protect the human sub-jects participating in the research and to assure the quality of the data being collected. Standardized training is also im-portant in the areas of data collection, data management and Background Dental practitioners (dentists and dental hygienists) have routinely provided oral health care to their patients based on the knowledge learned from their dental education, continu-ing education and the scienti ¿ c literature. Following in the path of the medical ¿ eld, there is a trend for clinical practi-tioners to collaborate with dental researchers and integrate research into their clinical practice. This type of collaboration has shown to directly impact the way the dental team pro-vides oral health care to their patients. With the development of evidence-based dental practice (EBDP) in the United States in the 1970s, a movement began for clinical research to take place in what are termed practice-based research networks (PBRNs). 1 The purpose of these networks is to join practitioners with academics in developing and answering relevant research questions that directly im-pact daily clinical practice. 2 With studies developed by private practitioners and conducted in the private practice setting— where the majority of Americans receive their care—results become more relevant to clinicians and lead to improved and applicable clinical treatment in a shorter amount of time as compared to conventional clinical research. 3 PBRNs offer unique advantages both to research and quality improvement because they have the potential to move scienti ¿ c advances into daily practice quickly, bring practice-relevant topics for research projects, and foster information sharing between practitioners. 4-6 There is little information in the dental literature about the skills or the expertise required to integrate dental research into a clinical environment. Over the last decade, basic and clinical research have been incorporated into dental and dental hygiene curriculums, with the hope that introduc-ing these concepts early on will motivate students to adopt evidence-based dentistry in their own practices and incorpo-rate these lessons in the care they provide to their patients. 7 A recent survey of dental hygienists showed that receiving a basic foundation of research in their education and having access MAR 2012 19

Clinical Feature

Jan Carlton Holland

Integrating Research into Clinical Practice Introduction Throughout one’s career, there can be a desire for new challenges, independence, new direction and a new focus while remaining within the scope of a profession. Incorporating clinical research into a professional routine, whether it’s within a private practice or an educational environment, is a new direction that is becoming increasingly more attractive and can be a natural transition for the practicing dental hygienist and dental team. This paper is the result of the information acquired from a team of dental practitioners who were brought together to prepare and conduct a National Institute of Dental and Craniofacial Research (NIDCR) funded, three-year, multicenter, randomized, placebo-controlled, double-blind study to determine the effectiveness of xylitol mints in reducing the incidence of coronal and root caries in caries-active adults. The authors hope to provide insight into the skills, processes and challenges involved in integrating research into a clinical environment, and what can be learned to help the reader prepare for a possible new direction within their profession. Background Dental practitioners (dentists and dental hygienists) have routinely provided oral health care to their patients based on the knowledge learned from their dental education, continuing education and the scienti..c literature. Following in the path of the medical ..eld, there is a trend for clinical practitioners to collaborate with dental researchers and integrate research into their clinical practice. This type of collaboration has shown to directly impact the way the dental team provides oral health care to their patients. With the development of evidence-based dental practice (EBDP) in the United States in the 1970s, a movement began for clinical research to take place in what are termed practicebased research networks (PBRNs).1 The purpose of these networks is to join practitioners with academics in developing and answering relevant research questions that directly impact daily clinical practice.2 With studies developed by private practitioners and conducted in the private practice setting— where the majority of Americans receive their care—results become more relevant to clinicians and lead to improved and applicable clinical treatment in a shorter amount of time as compared to conventional clinical research.3 PBRNs offer unique advantages both to research and quality improvement because they have the potential to move scientic advances into daily practice quickly, bring practice-relevant topics for research projects, and foster information sharing between practitioners.4-6 There is little information in the dental literature about the skills or the expertise required to integrate dental research into a clinical environment. Over the last decade, basic and clinical research have been incorporated into dental and dental hygiene curriculums, with the hope that introducing these concepts early on will motivate students to adopt evidence-based dentistry in their own practices and incorporate these lessons in the care they provide to their patients.7 A recent survey of dental hygienists showed that receiving a basic foundation of research in their education and having a mentor in this area of concentration were essential factors for integrating clinical research into their profession.8 Layher discusses the importance in preparing for a study, and the significance of organizing all aspects of the study. Mentoring from the site investigator and/or the sponsoring research organization can assist with the preparation and day-to-day operations of a clinical research study.9 Common Components and Characteristics of Practice- Based Research Projects Because each clinical study varies by its subject matter, funding resource, enrollment size, target population and study design, there is not a standard instruction manual for a dental team to follow from start-up to conclusion. The majority of dental practices that have integrated research into their daily job responsibilities receive on-the-job training, with the preparation and actual conducting of the study from either dental faculty or research professionals who have the knowledge base and skills to conduct dental research. The research team is composed of clinical and nonclinical personnel with varied backgrounds and experience. Each person involved will take on specic roles. The principal investigator (PI) oversees the research study from conceptualizing and writing the grant proposal through study closure, and makes the final decisions for their specic site; the study coordinator (SC) is the day-to-day manager of the study. The majority of the job activities for a study tend to fall under the responsibility of the study coordinator; the examiner (E) can be the dentist or dental hygienist, depending on the study. This person is trained and calibrated to evaluate aspects of relevant study variables such as dental decay, periodontal disease, or in the application of study medications or dental materials. The recorder (R) works with the examiner in recording and documenting treatment. Other study staff roles may be specific to a study or to a site (See Table I). Each person involved in the clinical research requires training prior to and throughout the study to comply with federal regulations and research guidelines for the protection of human subjects and to ensure the quality of the data is protected.10 This training includes: Health Insurance Portability and Accountability Act (HIPAA) for confidentiality requirements; Good Clinical Practice (GCP) guidelines in accordance with the U.S. Food and Drug Administration Code of Federal Guidelines; and the Protection of Human Subjects training is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical studies.The goals of GCP guidelines are to protect the human subjects participating in the research and to assure the quality of the data being collected. Standardized training is also important in the areas of data collection, data management and The procedures and process that make up the intervention detailed in the protocol. The private practice or institution where the study will take place (site) may require speci..c and specialized GCP training for all staff prior to study start-up. This training helps to ensure that all study staff know how to provide the intervention and collect the data in the same manner across all sites. It is especially important to ensure that staff collecting the exams or primary outcome data is calibrated to ensure that collected data are standardized. In order to make sure the rights of research participants are protected, an Institutional Review Board (IRB) must review projects funded through federal agencies prior to the start of a study. In general, most settings will require that all studies involving human subjects be reviewed and monitored. The study protocol and consent form must be submitted to an IRB before participants can be seen.An IRB is not only responsible for ensuring that participants will be protected, but also that the study is scientifically sound and ethical. If a study protocol uses a product regulated by FDA, FDA may also need to review the protocol with the option to request changes before the study can proceed. A means of organization and providing information to the dental team is with the use of a Manual of Procedures (MOP). The purpose of the MOP is to establish clear policies and procedures for a variety of critical decisions in the operation of the trial.11 This document describes the background, detailed logistics of the study and necessary tasks to complete each stage of the study. Specific chapters within the MOP are included to assist in the day-to-day function and can include trial administration and organization of the study, training and monitoring of the team, quality assurance, documentation, recruitment and screening procedures, enrollment, study material packaging and dispensing, examination procedures, data collection, data entry and management, retention and adherence, and reporting of adverse events and study closure. The Role of the Dental Hygienist in Practice-Based Research Dental hygienists are well-suited for conducting research in a clinical setting. There are many roles the hygienist can ..ll in a clinical research study, including the role of study coordinator, examiner, recorder or even the principal investigator. The education, training and experiences they possess make them uniquely capable of participating in practice-based research. Since attention to detail is already an essential part of the dental hygienist’s responsibilities, the introduction of clinical research into the dental hygienist’s daily schedule can be a relatively smooth transition. Research requires a heightened attention to detail because of the issues of privacy, protection of human subjects, and adherence to the written protocol. Research also requires the dental hygienist to learn new skills, such as how to manage research data, which is similar to managing patient medical records, but also has its own management principles and requirements. To balance the daily schedule of providing oral health care to patients and conducting research on human subjects, the dental hygienist and other members of the research team may need to adapt to new routines in their daily practice. The issues they face bring with it exciting opportunities and the chance to contribute to the knowledge base of the practice of dentistry. Conclusion In 2004, the American Dental Association conducted a survey of its members asking specific questions related to clinical research and how they believe it would affect the way they practice dentistry.Eighty percent of the members felt it was critical to follow treatment guidelines based on clinical research. The dental clinicians already involved in practice-based research felt their patients were benefiting from the integration of research in their private practice.12 Once a dental team masters the research protocol and understands the framework of a clinical study (grant, protocol, consent, IRB, HIPAA, GCP, inclusion/exclusion, recruitment and retention), the subject matter will change with each study and with that change come new learning opportunities, new skills, new challenges, and possibly a new way in which to provide oral health care. The authors hope that this paper has provided an insight to those in a clinical environment who may be considering or who are already in the process of integrating dental research into their profession. The integration of research can be a means for career growth and increased job satisfaction. Jan Carlton Holland, RDH, MS, is adjunct associate professor, Department of Dental Ecology, University of North Carolina, Chapel Hill, N. C. Muna Anabtawi, DDS, is instructor, Department of General Dental Sciences, University of Alabama at Birmingham, School of Dentistry, Birmingham, Ala. Sonia Makhija, DDS, MPH, is assistant professor, Department of General Dental Sciences, University of Alabama at Birmingham, School of Dentistry, Birmingham, Ala. Kimberly A. Funkhouser, BS, Kaiser N. Interstate Services Building, Dental Clinic, Portland, Ore. Debbie Robinson, CDA, MS, is assistant professor, Department of Operative Dentistry, University of North Carolina, Chapel Hill, N.C. Acknowledgment Grant Number: U01-DE017753 funded by the National Institute of Dental and Cranial Research (NIDCR). University of North Carolina, Chapel Hill provided additional financial support. References 1. Pearce KA, Love MM, Barron MA et al. How and why to study the practice content of a practice-based research network. Ann Fam Med. 2004; 2: 425-8. 2. Fagnan LJ, Morris C, Shipman SA, et al. Characterizing a practice-based research network: Oregon rural practice-based research network (ORPRN) survey tools. J Am Board Fam Med. 2007; 20: 204-19. 3. Mjör IA, Gordan VV, Abu-Hanna A, Gilbert GH. Research in dental practice. Acta Odontol Scand. 2005; 63: 1-9. 4. Mold JW, Peterson KA. Primary care practice-based research networks: working at the interface between research and quality improvement. Ann Fam Med. 2005; 3: S12-S20. 5. Green LA, White LL, Barry HC, et al. Infrastructure requirements for practice-based research networks. Ann Fam Med. 2005; 3: S5S11. (PubMed 15928219). 6. Lenfant C. Clinical research to clinical practice: lost in translation? New Engl J Med. 2003; 349: 868-74. (PubMed: 12944573). 7. Jones DL, Hinton RJ, Dechow PC, et al. Texas Dent. 2011; 128(2): 177-80. 8. Stanley J, Kenney J, Gwozdek A. Assessment of the skills and education necessary for a baccalaureate prepared dental hygienist to pursue an entry level role in clinical research. American Dental Hygiene Association 87th annual meeting, 2010. 9. Layher MG. One dental hygienist’s role in clinical research. J Dent Hyg. 2007; 81(3): 61-63. 10. DeRouen T, Hujoel P, Leroux B, et al. Preparing practicing dentists to engage in practice-based research. J Am Dent Assoc. 2008; 139(3): 339-45. 11. Bader JD, Robinson DS, Gilbert GH, et al. Four “lessons learned” while implementing a multi-site caries prevention trial. J Public Health Dent. 2010; 70: 171–5. Doi: 10.1111/j.1752-7325.2010.00167. 12. American Dental Association, Survey Center. The 2004 survey of dental practice. Chicago: American Dental Association; 2006. Table I. Research Teams Roles and Responsibilities Principle Investigator (PI) Execute the project as outlined in the funded proposal Carry out the project’s ..nancial plan as presented in the funded proposal Report project progress to the sponsor Maintain an accurate record of project related expenses Assembling the clinical team Communicate with the research team Comply with policies and procedures related to project management and personnel practices Comply will all applicable sponsor rules, regulations and/or terms and conditions of the funding Present scienti..c papers Study Coordinator (SC) Protocol (MOP) construction/update Clinical trial preparation Development and evaluation of patient information Informed consent forms Using and developing clinical research forms Filing and archiving Patient recruitment Scheduling Regulatory and ethical submissions (IRB) Implement clinical trial from initiation through stages of development, documents, SOP, organization facilities and credentialing Screening and enrollment of patients Communication with sponsor and authorities Product accountability Time management Data collection and management Queries Trial closure Examiner (E) Follow protocol for their speci..c task Maintain a high level of competency in their role Comply with training and preparation for the task Maintain con..dentiality with patients Attend on-going training/calibration sessions Participate in inter and intra-rater reliability measures Recorder (R) Follow protocol for their speci..c task Familiarize themselves with documents of the study Follow protocol when recording study information Maintain con..dentiality with patients and information gathering

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