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Evidence-Based Practice: Toward Optimizing Clinical Outcomes PDF

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Evidence-Based Practice: toward Optimizing Clinical Outcomes Francesco Chiappelli (Editor) Xenia Maria Caldeira Brant Negoita Neagos Oluwadayo O. Oluwadara Manisha Harish Ramchandani (Co-Editors) Evidence-Based Practice: toward Optimizing Clinical Outcomes Prof. Dr. Francesco Chiappelli Dr. Oluwadayo O. Oluwadara ADA Champion, Evidence-Based Dentistry University of California, Los Angeles Divisions of Oral Biology and Medicine School of Dentistry and Associated Clinical Specialties (Joint) Divisions of Oral Biology and Medicine University of California, Los Angeles Los Angeles, CA 90095-1668 School of Dentistry USA Divisions of Oral Biology and Medicine [email protected] Los Angeles, CA 90095-1668 USA Dr. Manisha Harish Ramchandani [email protected] University of California, Los Angeles School of Dentistry Prof. Dr. Xenia Maria Caldeira Brant Divisions of Oral Biology and Medicine Rua Aimorés 2480/609 Los Angeles, CA 90095-1668 Belo Horizonte-MG USA Brazil [email protected] [email protected] Dr. Negoita Neagos University of California, Los Angeles School of Dentistry Divisions of Oral Biology and Medicine Los Angeles, CA 90095-1668 USA [email protected] ISBN: 978-3-642-05024-4 e-ISBN: 978-3-642-05025-1 DOI: 10.1007/978-3-642-05025-1 Springer Heidelberg Dordrecht London New York Library of Congress Control Number: 2010923771 © Springer-Verlag Berlin Heidelberg 2010 Chapter 13 is published with kind permission of © John Wiley & Sons Ltd. 2009. All Rights Reserved. This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer. Violations are liable to prosecution under the German Copyright Law. The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Product liability: The publishers cannot guarantee the accuracy of any information about dosage and appli- cation contained in this book. In every individual case the user must check such information by consulting the relevant literature. Cover design: eStudio Calamar, Figueres/Berlin Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com) Foreword Evidence-Based Decision-Making in Health Care: Implications and Directions for the Future In the current political climate, health care is in crisis with no conceivable, long-term solution. Its future portends a shortage of primary care physicians with an estimated 50 million new patients needing basic health care [1]. It is expected that in the next decade 40,000 medical providers must be added to the existing 100,000 or the system for health care response to expected need will be overwhelmed. While the agenda for universal health care and reform has become a major stimulus for political action, dentistry has provided concrete advances in knowledge, technology, and mechanisms toward credible and practical responses to this crisis. These advances come in the form of new knowledge and research into oral bio- markers in screening for systemic diseases with mechanisms to systematically review published information for best evidence, and practical models to implement this best evidence for service providers and their patients. This implementation is integrated into the shared decision-making, patient assessment, evaluation, and treatment plan- ning encounter occurring within real timeframes and without disturbing practice rou- tines. The effort of dentistry to provide these workable solutions is particularly profound in that the knowledge, mechanisms, and models offered attempt to maxi- mize effective, efficacious, and cost containment treatment options for patients with best health care evidence for all within the dynamics of change in knowledge and treatments. Thus, there is a paradigm shift occurring in the concept of health care practice in general and dental practice in particular. The approach to patient-centered care is envisioning dental practice as part of primary care, creating a concept in which dental practice has expanded to become a center for dental medicine and oral health well- ness. Evidence of this paradigm shift is the work being done by David Wong in sali- vary diagnostics. Malamud [2] extols this new approach as “point-of-care (POC)” diagnostics that will revolutionize the way a limited amount of resources may be used to handle increased patient loads, providing the ability to diagnose disease condi- tions: reciprocal and inclusive of those performed in diagnostic medicine. Here, a “noninvasive, well-tolerated” oral sampling may be used to identify biomarkers in diagnosing disease at initial or periodic dental maintenance visits. As part of primary care, dental providers become part of the interdisciplinary team whose responsibility is to manage health care, including dental services, for shared patients. This health care management and service delivery may occur in hospital, v vi Foreword nursing home, or private practices and clinics. For dentists, or any health care pro- vider, this requires a knowledge base for interpretation of data and translation of its information into service or treatment options. EBR and translational evidence mecha- nisms are needed to provide trusted best evidence to perform within the dynamics of this new concept of dental practice. There are two major categories within which EBR has provided to meet changes in future health care practices. One has been in the reasoning of evidence and the other in application of this reasoning to improving patient decision-making in the presence of uncertainty about health care options, their value to individuals, and cost trade-offs. Evidence-based advances in reasoning have expanded knowledge or data to include the value and application of best evidence to patients and society. Current mechanisms include comparative effectiveness research (CER) and EBR. CER may be independent or synergistic with EBR. CER both conducts studies and uses system- atic review analyses to compare similar treatments or procedures in maximizing the choice of the most effective cost/benefit option within the context of new evidence [3]. EBR uses similar analyses; however, the result is to determine best evidence in maxi- mizing best outcomes not costs. Clinicians use these advances to promote shared understanding and decision-making in providing informed consent as well as oral health services and their maintenance along with disease control in individuals, their patients [5]. While CER and EBD in health care assist in reasoning individual health and treat- ment choices during shared-decision making with dentists, translational evidence mechanisms explain the development of data, its transformation into best evidence, clinical relevance, and meaning in practice. These mechanisms, which rely on human information technology (HIT) systems, propose to understand, define, and characterize the underlying process involved in clinical decision-making for CER and EBD. For health care in the twenty-first Century, the triad of CER-EBD-HIT defines the com- pact between researcher (research synthesis), clinician (clinical expertise, local long- term monitoring and implementation of evidence), patients (patient choice and compliance) in providing the essential components of the biological, behavioral, and social interventions involved in clinical decision-making related to health care delivery, and coverage of costs by third-party providers [4]. The future of these advances is profound for patients because dentists and physi- cians are known for providing services, treatments, and therapies in the nongovern- mental, private business sector that responds to market forces in maximizing effective, efficacious, and cost containment for oral health care and service delivery. Dentistry and medicine, as well as nursing and allied health care professions, function as part of the primary care – interdisciplinary team systems approach. This is a reality today, which will subsist in coming decades. Therefore, the contributions contained within this book explain the advances made in evidence-based and CER for decision-making in health care. This literature pro- vides the background and knowledge of the development, validation, and implemen- tation of research methodologies and mechanisms in providing relevant and practical solutions for physicians, dentists, nurses, and patients. These advances are timely in their promotion of best evidence used in informed consent and assisting the choices and trade-offs patients often are required to make when uncertainties in health care choices and options arise. The benefit of these developments toward resolving the current crisis in health care delivery nationally and internationally is critical and Foreword vii timely as it proffers practical models for translating the best available research evi- dence to patients and society for improvement in health care and well-being of the patient populations we serve. Janet G. Bauer, DDS, MSEd, MSPH, MBA Associate Professor and Director June and Paul Ehrlich Endowed Program in Geriatric Dentistry UCLA School of Dentistry 23-088E CHS, 10833 Le Conte Avenue Los Angeles, CA 90095-1668, USA References 1. Associated press: 50 million new patients? Expect doc shortages. Revamped health care system could swamp primary care physicians. [article online] cited 14 September 2009. Available from: http://www.msnbc.msn.com/id/32829974 2. Malamud D (2006) Salivary diagnostics: the future is now. J Am Dent Ass 137:284–286 3. A new analysis released by the RAND Corporation (8 September 2009) suggests that while there are benefits to having better information for health care providers, third-party providers (e.g., insurance companies), and patients about what works best in treating different health problems short-term, it is uncertain that comparative effectiveness research will lead to reductions in spend- ing and waste or improvements in patient health…. “there is not enough evidence at this point to predict exactly what the result might be for the cost of the nation’s health care system..” Elizabeth McGlynn, codirector of COMPARE, RAND Corporation http://www.randcompare.org/publica- tions/summary/comparative_effectiveness_research_may_not_lead_to_lower_health_ costs_or_improve_health_analysis_finds 4. Chiappelli F, Cajulis O, Newman M. Comparative Effectiveness Research in Evidence-Based Dental Practice. J Evid Based Dent Pract 2009 9:57–8 5. Chiappelli F, Cajulis OS. The logic model in evidence-based clinical decision-making in dental practice. J Evid Based Dent Pract 2009 9:206–10 Preface Just over 10 years ago, the American Dental Association produced its original policy statement on evidence-based dentistry (February, 1999). Later that year, a colleague at UCLA School of Dentistry, Professor Lindemann, told me “Francesco, you really should look into this evidence-based dentistry.” His suggestion changed my research direction, and, I suppose, that moment was the true genesis of this book. Of course, the movement toward evidence-based practice in dentistry had been ushered in a few years earlier by medicine (evidence-based medicine). The notion had spread fast both nationally and internationally and across fields, and, within a few years, one could find common references to evidence-based nursing, evidence-based specialties across the branches of health care, and even evidence-based law, econom- ics, and the like. As I began to explore the field, I was fortunate to develop colleagues interested in evidence-based research (EBR) and decision-making in the health sciences in general, and in dentistry in particular, across the globe. Students and post-docs in my research group became increasingly actively engaged in this new and cutting edge field, and we soon published a carefully crafted definition of the meta-construct of evidence-based dentistry [1], and of salient issues in this emerging field [2]. In 2003, the Brazilian Journal of Oral Sciences invited me to be the guest editor of a special issue dedicated to evidence-based dentistry – to my knowledge, the first ever peer-reviewed journal dedicating a special issue to evidence-based dentistry. By 2006, when the California Dental Association Journal invited me to do the same, evidence- based dentistry was fast becoming established in the national and international dental literature. Working on both these issues was transforming, that is, it gave me a broad awareness of the depth of the field, its potentials, impediments, hurdles, and benefits. It was during that time that my students, coresearchers, and I realized the method- ological void that still remained to be addressed in the field. We developed the Wong scale [3] to assess and to quantify the quality of the research methodology, design, and data analysis based on commonly accepted criteria, and soon revised it and improved its validity and reliability [4]. We refined our skills in research synthesis, and in our ability to generate the best available evidence, be it in dentistry, medicine, alternative and complementary medicine, or any domain of the health sciences [5]. We realized that, whereas our research group was well versed in obtaining a consen- sus of the best available evidence, we had done little in terms of utilizing the evi- dence-based paradigm to optimize clinical outcomes. We were aware of the need to fill the gap between clinical practice based on the evidence, patient-oriented evidence that matters (POEM), and research synthesis (or, specifically for the field of dentistry: research evaluation and appraisal in dentistry [READ]) [6], and endeavored to do more in that domain. Hence this book. ix x Preface Upon this fertile ground, an idea burgeoned, which we shared with Stephanie Benko at Springer, and the proposal for this comprehensive book addressing cutting edge issues about utilizing evidence-based concepts in clinical practice in order to optimize clinical outcomes was in the making. Soon, Irmela Bohn (Springer) stepped in the project, and we were most fortunate because, without Irmela’s expertise, patience, and guidance, the project would have remained just that: an idea – a good idea perhaps, but just an idea. I will never be able to thank Irmela enough for her dedi- cation, encouragement, and superlative hard work along the way. It was mainly because of her, and through her consistent support that the project really took a life of its own. And soon I was discussing it with selected colleagues in various countries – from Brazil to Nigeria, from Romenia to the US - inviting them to be on the editorial team. Together, we carefully chose the “rose” of experts in the field to invite to contribute chapters. Therefore, of course, I must thank profusely my friends and colleagues – Drs. Brant, Neagos, and Oluwadara – who worked long and arduous hours on this project as coeditors. Without them, the final product would never have achieved the level of perfection and excellence it has. My profound thanks, which I know are shared as well by the coeditors, go to the authors of the chapters in this work. They wrote assiduously, edited and perfected their chapters patiently responding to each and every one of Irmela’s and my and the coeditors’ requests for timeliness, precision, format, and all the possible details one could imagine. It is their expertise and their dedication to this project that makes this book the superb ouvrage and the timely and critical anthology of evidence-based decision (EBD)-making in health care the high quality product that it is. Los Angeles, California, USA Francesco Chiappelli References 1. Chiappelli F, Prolo P (2001) The meta-construct of evidence based dentistry: Part I. J Evid Based Dental Pract 1:159–165 2. Chiappelli F, Prolo P, Newman M, Cruz M, Sunga E, Concepcion E, Edgerton M (2003) Evidence- based dentistry: benefit or hindrance. J Dental Res 82:6–7 3. Wong J, Prolo P, Chiappelli F (2003) Extending evidence-based dentistry beyond clinical trials: implications for materials research in endodontics. Braz J Oral Sci 2:227–231 4. Chiappelli F, Prolo P, Rosenblum M, Edgeron M, Cajulis OS (2006) Evidence-based research in complementary and alternative medicine II: the process of evidence-based research. Evid Based Complement Altern Med 3:3–12 5. Chiappelli F (2008) The science of research synthesis: a manual of evidence-based research for the health sciences – implications and applications in dentistry. NY, NovaScience, pp 1–327 6. Chiappelli F, Cajulis OS (2008) Transitioning toward evidence-based research in the health sci- ences for the XXI century. Evid Based Complement Altern Med 5:123–128 Acknowledgements This work would not have been possible without the arduous and serious dedication of the many predental students who, in the past several years, have contributed to our research groups. Most of them have found over the years a most deserved acceptance into dental school, some jointly with a Master’s degree or even a PhD degree. To name only a few, I wish to commend Dr. Jason Wong for his original work on the Wong scale, and Dr. Jason Kung for his original work on the revision of the AMSTAR. I also want to mention particularly Ms. Audrey Navarro (dental student and PhD candidate), Mr. David Moradi (dental student and Master’s candidate); and Ms. Raisa Avezova, Mr. George Kossan, Mr. Cesar Perez, Ms. Linda Phi, and Ms. Nancy Shagian, predental students, for their current contribution to our research progress in EBD-making. By their assiduous dedication to forwarding the field of research syn- thesis for EBD-making and for comparative effectiveness analysis, they enact the beautiful words uttered not so long ago by the French writer Antoine de Saint-Exupéry (29 June 1900 – 31 July 1944): “Fais de ta vie un rêve et de tes rêves la réalité…” I thank colleagues at UCLA and beyond for their precious intellectual contribu- tions, especially Drs. Janet Bauer, Carl Maida, and Jeanne Nervina, and the Evidence- Based Dentistry Center at the American Dental Association. I thank the UCLA Senate for funding in support of this and other research endeav- ors by my group. And most of all, I, on behalf as well of the coeditors of this work, profusely thank Ms. Irmela Bohn of Springer (Heidelberg, Germany) for her kind support, patience, and guidance in making this anthology of EBD-making the high-quality product that it is. I dedicate this and all of my academic endeavors to Olivia, to Aymerica and to Fredi, and to honor …la gloria di Colui che tutto move/per l’universo penetra e ris- plende/in una parte più e meno altrove…(Dante Alighieri, 1265–1321; La Divina Commedia, Paradiso, I 1–3). xi Contents Part I: The Science of Research Synthesis in Clinical Decision-Making 1 Introduction: Research Synthesis in Evidence-Based Clinical Decision-Making .................................... 3 Francesco Chiappelli, Xenia M.C. Brant, Oluwadayo O. Oluwadara, Negoita Neagos, and Manisha Harish Ramchandani 2 Overview, Strengths, and Limitations of Systematic Reviews and Meta-Analyses.......................................... 17 Alfred A. Bartolucci and William B. Hillegass 3 Understanding and Interpreting Systematic Review and Meta-Analysis Results ................................... 35 Cristiano Susin, Alex Nogueira Haas, and Cassiano Kuchenbecker Rösing Part II: Making Evidence-Based Decisions 4 Making Evidence-Based Decisions in Nursing ................... 53 Corazon B. Cajulis, Pauline S. Beam, and Susan M. Davis 5 A Model for Implementing Evidence-Based Decisions in Dental Practice........................................... 67 Clovis Mariano Faggion Jr., Stefan M. Listl, and Marc Schmitter 6 Evidence-Based Decisions in Human Immunodeficiency Virus Infection and Cardiac Disease ........................... 79 Raluca Arimie and Zohreh Movahedi 7 Bringing Evidence Basis to Decision Making in Complementary and Alternative Medicine (CAM): Prakriti (Constitution) Analysis in Ayurveda........................................ 91 Sanjeev Rastogi and Francesco Chiappelli xiii

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