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Comparative Effectiveness Research and the Chiropractic Profession
EDITORIAL COMPARATIVE EFFECTIVENESS RESEARCH THE CHIROPRACTIC PROFESSION
AND
Claire Johnson, DC, MSEd
ABSTRACT The purpose of this article is to discuss comparative effectiveness research (CER) as it relates to the chiropractic profession. This article reviews CER priorities as determined by the Institute of Medicine and suggests actions for the chiropractic profession to become more involved in CER. (J Manipulative Physiol Ther 2010;33:243-250) Key Indexing Terms: Comparative Effective Research; Chiropractic Profession
n the United States, we are facing a health care crisis. Although there have been improvements in various medical and public health innovations, we are still experiencing increasing costs and disparities in services to portions of our population; not everyone has access to the health care that they need.1 Our population continues to age, and the average life expectancy continues to rise and we will observe growing costs associated with managing chronic conditions. As we struggle with health care reform, there are many obstacles that must be overcome to solve these problems. Thus, we are in search of clinically and cost-effective ways to best address the needs of individuals and populations. Although the information explosion from scientific research and the increased complexity of health care services seem to promise better health benefits, they have created a perplexing and costly maze for both patients and providers to navigate. At present, many people who seek care from one health care provider may not have coordinated care with other providers, which may result in duplication of services, or worse, adverse events that may harm patients' health. In this complicated environment, the concept of integrative health care (IHC) has evolved. Integrative health care is a cooperative model in which
I
Editor, JMPT, Professor, National University of Health Sciences, Lombard, Ill. Submit requests for reprints to: Claire Johnson, DC, MSEd, Editor, JMPT, Professor, National University of Health Sciences, 200 E. Roosevelt Rd, Lombard, IL 60148 (e-mail: [email protected]). 0161-4754/$36.00 Copyright © 2010 by National University of Health Sciences. doi:10.1016/j.jmpt.2010.04.001
health practices and practitioners coordinate together in the best interest of both patient and population health.2,3 In an IHC environment, it is important to select the most beneficial care for patients, avoid harmful treatments or side effects, and reduce costs. Thus, accurate and reliable information is needed when making health care decisions. Evidence-based practice (EBP) has promised to help address some of our health care information needs by using evidence to help clinical decision making. Evidence-based practice was first made popular in 1991 by Sackett and is the “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patient.”4,5 However, as with any tool, there are limits to EBP, and therefore, additional solutions are being sought. For example, it is estimated that less than half of medical practices are founded on scientific evidence,6,7 and it is unknown what percentage of other health professions' practices (eg, nursing, physical therapy, chiropractic, acupuncture) are scientifically based. Evidence-based practice typically is not able to bridge the gap when little or insufficient evidence is present. Under the present conditions, it would not be possible for any health care provider to practice using an “evidence-only” method. Therefore, additional methods are needed to help practitioners select the best methods to meet the health care needs of their patients. Comparative effectiveness research (CER) may offer solutions to address some of these needs. Comparative effectiveness research includes the principles and methods of EBP in addition to other methods and offers solutions to the issues that EBP is not designed to cover. 1,7-10 Comparative effectiveness research incorporates findings from research, identifies health needs and information gaps, 243
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looks for ways to close these gaps, and then implements them in real-world practice settings.8,9 Comparative effectiveness research also includes other factors that are important when making health care decisions, such as costs, population characteristics, available treatments options, delivery methods, diagnoses, and health care environment (eg, data from real-life practice may be preferred over data that are collected in a controlled setting). One might say CER is the next step in the evolution of scientifically based health care. In February 2009, President Obama signed into law the American Recovery and Reinvestment Act. This act dedicated $1.1 billion dollars in funding for CER and additional funding for the Institute of Medicine (IOM) to make recommendations and set CER priorities.11 The focus of CER is to directly compare risks and benefits of different treatments for a particular condition, which will impact how clinical decisions are made. Although these efforts are not meant to mandate coverage or reimbursement,11 information from these research efforts are expected to change how the practice and business of health care are being done in the United States. Seeing these changes on the horizon, it would be crucial for the chiropractic profession to be included in these efforts. The purpose of this article is to provide a brief introduction to CER and how the chiropractic profession might become more involved.
DEFINING CER The IOM defines CER as follows: “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.”7
The Federal Coordinating Council for Comparative Effectiveness Research provides the following definition: “Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in “real-world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.”8
Comparative effectiveness research promises to take the benefits of EBP and apply these and other attributes to population health.9 Whereas EBP focuses on applying critically appraised research to a clinically relevant question in the context of the best interest of the patient, CER additionally proposes to improve additional factors in health care at both patient and population levels.9 There are several motivations behind the CER movement in addition to improving patient care. One theme that
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recurs in CER literature is that CER may help to contain costs. For the past 10 years, health care costs in the United States have increased 2 and a half times the average of other similar countries.9 One might have expected that methodological and technological health care improvements that we have witnessed in the past decades would have reduced costs; however, these costs continue to rise. Both private and public spending for health care has increased, and federal spending on Medicare and Medicaid has tripled.9 Other concerns that have stimulated an interest in CER include the over use of treatments that may be harmful, not helpful to the patient, or simply a waste in spending. For example, Deyo et al12 found that although the Medicare population only increased by 12%, there was a 629% increase in Medicare costs for steroid injection for back pain. As well, through an analysis of National Medical Expenditure Panel Survey (MEPS) data, they found a 108% increase in opioid prescriptions and a 423% increase in costs for opioids for back pain.12 A study by Martin et al13 reviewed MEPS data from 1997 to 2005 to analyze expenditure and health outcomes. They found that in the United States there was an increase in spending for back and neck pain but without improvement in health outcomes. Another concern includes the variation in expenditures and quality of health care by geographic region. Fisher et al14 showed that in the United States, health care costs varied by region and higher costs did not necessarily correlate with better care or improved outcomes. Even when various factors were taken into consideration, such as cost of living and severity of illness, cost variation could not be accounted for. These facts lead us to ask if there are better ways to manage common conditions such as back pain and control costs of care. It is important to note that the United States is not the first to develop CER efforts. Other countries, such as the United Kingdom, Germany, France, Canada, Denmark, and Australia have programs already in place that evaluate cost and effectiveness of various health care methods.9,15 For example, the United Kingdom has the National Institute for Clinical Excellence that conducts systematic reviews on the cost-effectiveness of health care interventions. The National Health Service uses these reports to make health care coverage decisions in the United Kingdom. In Germany, the Institute for Quality and Efficiency in Health Care evaluates treatments and clinical practice guidelines. The Federal Joint Committee uses the Institute for Quality and Efficiency in Health Care reports to make health care coverage decisions in Germany. Therefore, if the United States were to follow the trend found in other countries, data and reports generated from CER would likely determine type of care allowed for a given condition and if the treatment would be covered.9,15 Comparative effectiveness research is not the only answer but one more way of looking at information to try to find better answers. Comparative effectiveness research
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compares various health care methods in a head-to-head fashion to inform decision makers about which type of care is more beneficial, is safer, and more cost-effective. Comparative effectiveness research focuses on evidence synthesis and systematic reviews in addition to other types of research designs. Once this information has been gathered and reviewed, new knowledge is developed or identified to fill information gaps. The final step is to communicate this knowledge to all the stakeholders such as patients, providers, payers, and policy makers. This last step, translation of research and knowledge into practice, must be accomplished if CER is to make a difference.
IOM SETS CER PRIORITIES
FOR THE
UNITED STATES
The American Recovery and Reinvestment Act of 2009 charged the IOM with conducting a study to determine research priorities for CER in the United States.7 The IOM crafted a list of priorities for CER through a labor-intensive process, which is summarized here. An ad hoc committee was created and solicited input in 3 ways. The first was to invite key stakeholders (eg, American Medical Association, Association of Schools of Public Health, Biotechnology Industry Organization, Blue Cross and Blue Shield Association, American Heart Association, National Pharmaceutical Council, and others) and the public to a conference to discuss issues of CER.7 The second was through the Internet using a Web-based nomination process to collect and establish priorities of the topics. The Web-based questionnaire collected 2606 topics from 1758 respondents. From this process, 1628 topics were selected to go on to prioritization. The third process included input from participants through the project's Web site. For the selected topics, the online questionnaire asked each respondent to support each nominated topic with specific information, include information to support the proposed research, suggest appropriate study populations, suggest what interventions might be compared, and propose research method.7 The next step created priority setting criteria. Two sets of criteria were used to evaluate each priority topic. The first was condition-level criteria (eg, burden of disease, prevalence, mortality, morbidity, cost, variability). The second was topic-level criteria (eg, appropriateness of the item, information gaps, use for decision making, risks associated with care, gaps in translation from research to practice). The committee used information from data bases such as from the Cochrane collaboration to determine existing research and MEPS data for information on cost, prevalence, and morbidity. After analyzing the information, the committee went through 3 rounds of voting to narrow down the list. The voting criteria included clinical category, study population, interventions, and research method. The resulting top 10 priority CER topics include the following
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areas: health care delivery, disparities, disabilities, cardiovascular, geriatrics, psychiatry, neurology, pediatrics, endocrinology, and musculoskeletal. After creating the priority-setting criteria, the IOM made recommendations to support CER. These recommendations included the following: prioritization of CER topics as a continuous process and the inclusion of input from all stakeholders, inclusion of public participation by using information from national data to identify diseases/conditions and research gaps, continued evaluation of prioritized topics through a quality improvement process, and regular reporting of research updates and findings through a federal organization to support databases and registries.7 The IOM committee also made recommendations about an infrastructure to maintain CER efforts, including the creation of an advisory body to help report on CER activities. It was suggested that the advisory body should include patients, providers, and researchers because each address health care from a different point of view. The committee recommended that the CER program develop new methods to address CER needs such as the use of observational data and development of more practically crafted clinical trials.7
IOM MUSCULOSKELETAL PRIORITIES One might ask if there is anything that the chiropractic profession could do to be more involved in CER. Because most of what we manage on a day-to-day basis is musculoskeletal in nature, it would make sense that this is one area that may be a good match. In the classification of CER priorities, IOM recognized that “musculoskeletal disorders” is a very broad topic. Therefore, they clarified the focus of this topic based upon Healthy People 2020 goals,16 which include neck/back pain and osteoarthritis. The criteria used to select these as priorities include that they are the most prevalent, costly, and morbid conditions. Areas for inquiry include establishing a registry to compare effectiveness of treatment strategies for low back pain, establishing a registry to compare effectiveness of surgical and nonsurgical methods for treating cervical spondylotic myelopathy, comparing effectiveness of treatment strategies for cervical disk and neck pain, comparing effectiveness of surgical strategies for patients in which nonsurgical care has failed, and comparing effectiveness of treatment strategies in the prevention of disability of osteoarthritis.7 Keeping these IOM priorities in mind, procedures or provider type that can influence these conditions should be included in future comparative analyses. This means that treatment from doctors of chiropractic or other styles of care for these conditions could be considered when developing CER strategies. Specifically 4 of the 5 priority topics could include nonsurgical and nonpharmaceutical interventions, which is a good fit for chiropractic care.
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It is estimated that more than $100 billion per year is spent in the United States on back pain.13 Chiropractors traditionally provide care to patients without the use of drugs or surgery,17 and evidence shows that chiropractic care can provide relief for back and neck pain conditions.18-20 As determined by the IOM, there is a priority for CER focusing on back and neck pain. There is also evidence that chiropractic is effective in managing back and neck pain, and chiropractic is an alternative treatment to surgical and pharmaceutical treatments. Therefore, it would make sense to include chiropractic as a treatment approach in the research agenda for CER.
POTENTIAL SOURCES FOR CER
OF
CHIROPRACTIC INFORMATION
National Health and Nutrition Examination Survey and MEPS Databases are available that could contribute to CER related to back pain and chiropractic care. The National Health and Nutrition Examination Survey collects information related to health and nutrition by survey and interview from American children and adults.21 The survey collects information about the prevalence of chronic conditions in addition to risk factors. Specific health conditions related to musculoskeletal conditions include osteoporosis, physical fitness, and physical function. The survey includes questions about medical and nonmedical providers seen, such as chiropractic, physical therapy, and osteopathy. In addition to the survey, a physical examination is performed by a medical physician. This information helps to identify the overall health of the population, what health conditions may be present, and what types of providers people are seeing. However, this information does not track treatment type or effectiveness with the specific condition a person may have. Nor does it measure treatment costs associated with these conditions. The MEPS is a part of the Agency for health care Research and Quality, a division of the US Department of Health and Human Services. Medical Expenditure Panel Survey is a set of large-scale surveys of families and individuals, their medical providers, and employers across the United States.22 This database can be accessed online, and various search strategies can be performed, including a search of chiropractic services. Other MEPS search categories include payer types including Medicare, federal, and private insurance payments. Although the MEPS information is important to track costs for expenditures of various provider types, this information does not necessarily connect to clinical outcomes. Questions that are not answered by these data are if the patients being seen by chiropractors are the same in age, complaint, severity, or income as those seeing other providers. The data do not inform us if the outcomes were similar, worse, or superior to other provider types for the same condition and severity.
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There is also no information about specific types of care offered by these services. There is a huge range of services offered by chiropractors, but it is not clear what is being provided in this database. Although there are not many published studies that describe chiropractic using MEPS, there are a few. In one example, Davis et al23 performed a study to investigate use and costs of chiropractic care between 1997 and 2006 using MEPS. They assessed the number of American adults who received chiropractic care, number of chiropractic visits, and used the inflation-adjusted costs. They found that the inflation-adjusted expenditures on chiropractic care increased from $3.8 to $5.9 billion; however, total expenditures per patient and office visit remained unchanged. On the basis of these findings, they concluded that the number of patients seeking chiropractic care has increased. Although this is not specifically a CER study, it demonstrates that evaluation of some chiropractic information can be completed and that further exploration of MEPS to answer CER questions may be fruitful.
Electronic Health Care Records Electronic Health Care Records (EHR) provide health care providers and public health service opportunities to improve processes.24 Electronic Health Care Records can be incorporated into decision support and expert systems to provide a framework for many functions. Electronic Health Care Records can collect information on individual patients as well as populations. Providers that are located in different areas but who are serving the same patient, such as with active duty military personnel, can easily access health records without having to wait for them to be sent in the mail. Coordination of services can be assisted by EHR by allowing health care coordinators to access care patterns and to make sure patients are being referred in a timely manner and that there are no duplication of services. For example, if a patient has recently received a magnetic resonance imaging scan on the area of complaint, there is no need to perform the scan again unless other factors warrant a repeat procedure. Electronic Health Care Records can also facilitate expert consultations from specialists who are not readily accessible due to geographic location. A health care provider at a rural location may be able to access a specialist from a distant location through the EHR. For example, by having digital imaging files stored in the health record, imaging experts can be consulted on the case and reports generated very quickly. Electronic Health Care Records can also assist providers with delivering care that is more in alignment with current health care guidelines.24 For example, programs can be set up so that well patient visits are included. The program can prompt the provider and the patient that certain activities such as health screenings may be needed at the next patient visit. If a checkup is needed,
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a reminder can be included with the patient's EHR. The EHR can also be used to track trends in health screening procedures. For example, the number of patients receiving mammograms at the recommended age for a high-risk subgroup of the population will help to direct the activities of the local public health services. Electronic Health Care Records are receiving more attention in the field of chiropractic.25 Fredricks et al25 suggest that chiropractors can use EHR to improve availability, accessibility, affordability, continuity, and quality especially as these relate to integration of chiropractic services within the larger health care system and IHC. Doctors of chiropractic are currently using EHR in two of the largest health systems in the US (ie, Department of Veterans Affairs and the Department of Defense).26 Electronic Health Care Records have been described as one method used to coordinate and facilitate integrated care in these environments.27 In these settings, the chiropractic provider enters all care notes into the HER and all other providers have access to these files. Patients can be more quickly directed to appropriate care, such as a patient with simple mechanical low back pain can be scheduled for a chiropractic visit instead of burdening the appointment waitlist for orthopedic surgery. There is hope that EHR will help to provide higher quality and more efficient care. However, the EHR system is not yet standardized across the United States, and not all locations have EHR systems. As these systems evolve and develop, more research can be achieved using EHR for CER. As one example of CER that can be performed using EHR, Crow and Willis28 performed a study that estimated costs for acute low back pain comparing standard care to manipulative treatment. This study reviewed the electronic medical records at one hospital in Florida for a period of 3 years. They compared a control group (receiving medical care) to those receiving manipulation and found a significant difference between the groups. The osteopathic group received significantly less diagnostic imaging (ie, 74% fewer radiographs and 90% fewer magnetic resonance imaging scans), and overall costs were lower by $38.26. Within an IHC system, communication, peer review, and monitoring of outcomes help to promote best practices. Electronic Health Care Records can provide a means for a variety of specialists and practitioners to communicate with each other and coordinate care. Electronic Health Care Records can also be used to track provider practices, such as in performance review, or track trends or effectiveness in treatment, diagnosis, and following established practice guidelines. Because information in EHR can be harvested, it is possible for data to be collected on outcomes for specific treatments, time to recovery, and quality of life measures. Another facet of health care is cost. Electronic Health Care Records can help to track practice patterns and provide information about costs of treatment for various conditions. This information can possibly be compared by
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region, by provider type, or treatment method.9 However, this information can only be compared and analyzed if it is entered into the system. Oftentimes chiropractic health care practices fall outside of the medical care system, may be practiced outside of a health care network, or are not included in an EHR. If chiropractic is not included in the EHR, information from these provider encounters will not be included in the data, and therefore, this section of the population will be invisible when it comes time for decision making in policy and health care practices. Thus, it is important to include chiropractic in EHR so that it may be included in the CER process.
Other Information Sources There are other potential sources that may be able to provide primary and secondary chiropractic information for inclusion in CER efforts. Information from insurance companies, third party payors, or institutions that are dedicated to collecting and evaluating this information may be helpful in contributing to the CER infrastructure. For example, Sarnat et al29 analyzed clinical and cost use data from an integrative medicine independent physician association whose primary care physicians were doctors of chiropractic. Information was analyzed for clinical use, cost, and satisfaction. They found that chiropractors in this organization using nonsurgical and nonpharmaceutical approaches demonstrated reductions in both clinical and cost use compared to using conventional medicine alone. In another example, Grieves et al30 performed a study that evaluated data from a managed care organization. They looked at differences in cost for managing low back pain by medical doctors compared to doctors of chiropractic in an integrated care environment. They found that chiropractic management was less expensive than medical management of low back pain when care extended beyond primary care and that primary care management alone for low back pain was indistinguishable from chiropractic management in costs. In a different study, Sharma et al31 evaluated practice-based research data for short-term and long-term determinants of costs and pain improvement for care of low back pain comparing treatment provided by medical doctors to doctors of chiropractic. Thus, primary data from various records, such as from practice-based research, independent physician associations, or managed care organizations, may provide helpful information to CER. As well, entities that focus on systematic reviews, such as the Cochrane Collaboration or the Agency for health care Research and Quality, have teams of people actively involved in finding and summarizing research information. These teams perform secondary CER studies using information from the literature. They gather information based upon a list of criteria then pool the information and analyze it to determine which procedures or methods are
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scientifically based and which are safe and/or clinically superior to another method.
OBSTACLES
FOR INCLUSION OF
CHIROPRACTIC
IN
CER
To support research efforts that will generate and synthesize evidence that compares benefits and harms of methods that will prevent, diagnose, and treat various conditions, a strong research infrastructure must be in place. There are several criteria for an item to be included in a national CER program. As described earlier, through the efforts of IOM, a need must be established to set a topic as a priority. It is interesting to note that no chiropractic-related groups were represented on the list of stakeholders named in the report.7 There may be several reasons for this lack of representation; however, a chiropractic voice representing conservative care for spinal conditions without the use of surgery or pharmaceuticals did not seem to be at the table. This suggests that there may be future opportunity for chiropractic groups to participate and contribute to the ongoing IOM CER efforts. The IOM priority topic of musculoskeletal conditions (eg, including back and neck pain and osteoarthritis) is a good match for chiropractic services. It would seem that a comparison of chiropractic services with other services would be relatively easy. However, in some situations, the coding system may be set up so that the only way that chiropractors may get reimbursed is to use a separate code from what other health care providers are using. The 739 International Classification of Diseases diagnosis code is for a “nonallopathic” lesion and is the code that most chiropractors use when billing or recording care. However, this code is not well defined, and other providers may also use this code with a different purpose in mind. This generates a problem when trying to compare 2 different treatments of a group of patients with like diagnoses. Treatment codes are also difficult to identify. For example, if a code used for chiropractic manipulation is required for reimbursement, however, no other adjunct procedures are recognized by the system, it may not provide the complete clinical picture. It is possible that these adjunct procedures are essential to patient improvement but might not be included in the database. Within the chiropractic profession, there are a great variety of styles of chiropractic manipulation. Thus, simply evaluating a code for “manipulation” is almost meaningless. This suggests that greater clarification and standardization of how chiropractic diagnoses and treatment procedures are recorded, especially in the EHR, are necessary. The research processes of CER will require the completion of systematic reviews. Thus, a complete and up-to-date knowledge/bibliographic database will be required. Once the current literature has been collected, group consensus processes will assess the findings, and best practice decisions will need to be made, such as what was
done by the Council on Chiropractic Guidelines and Practice Parameters.32-38 From these, information gaps will be identified, and a research agenda will be formed. While this agenda is being created, the type of research will be considered, such as if additional randomized controlled trials are needed or if population-based studies are more appropriate. Unless we have an entity in the chiropractic profession that is willing to support these ongoing efforts with skilled people and funding, performing these processes will not be possible. A few of the national databases that track expenditures include mention of chiropractic services but not necessarily in enough detail to determine important factors, such as cost benefit compared to other procedures, potential harm or adverse effects, and overall health outcomes of the patient receiving various types of care for neck or back pain. Although chiropractic care has been shown to be useful and safe for various conditions, many medical facilities do not include chiropractic services. If a health plan includes chiropractic care, these may be accessed off site and/or not included within the larger health care system. Many chiropractors work in solo or small group practices; thus, inclusion in EHR may be either nonexistent or slowly implemented, which causes a problem with being included in CER. When comparing costs, multiple health factors should be considered. These include improvement in function, reduction in pain, number of visits to the provider, and long-term outcomes (eg, does the patient stay well over time). These suggest that we need to work toward providing more opportunities for chiropractors to be integrated within the health care system and include more meaningful and transparent details about chiropractic services in the EHR.
SUGGESTIONS Whether we like it, what we do, how well we do it, and how much our services cost will be compared to other health care services and professions. These results may further strengthen the position of the chiropractic profession within the health care system or they may result in a devastating blow. How we respond to CER may determine our fate. The following list, though not all-inclusive, suggests several items for the chiropractic profession to consider.
Costs As a profession, we need to focus on what we can do to increase quality and keep costs down. Instead of trying to figure out how we can bill more per patient, we need to figure out how to get our patients better faster, in a safer manner, and for less cost than other competing methods. Although it may seem counterintuitive to some in private practice who are trying to make ends meet in these tough economic times, if we are able to control costs, the scientific evidence will show that chiropractic is the
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method of choice and we will be assured a place in the health care marketplace. However, if we continue to search for ways to increase our reimbursements per case, although this may be a short-term gain for a few individuals, it will result in excluding or even possibly eliminating chiropractic care from the health care system.
Research Agenda Establishing a functional, relevant, and responsible research agenda is essential to being included in CER. We need to better communicate so that each institution that conducts chiropractic research is coordinated with other institutions in their research efforts. Although there is some very interesting research being produced, it is unclear how these uncoordinated efforts may fit into daily practice or how they could contribute to CER. As well, it is important that our current and future researchers be well trained with skills that are relevant to CER so that they can become active participants.
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developing a strong research agenda, collaborating, and controlling costs, the chiropractic profession has the potential to participate actively in CER and to improve patient care outcomes.
FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST No funding was received for this article. Disclosure statement: Claire Johnson, DC, MSEd, is the editor of the JCM, a full-time professor at the National University of Health Sciences, peer review chair for the Association of Chiropractic Colleges, a board member of NCMIC, and a member of the American Chiropractic Association, American Chiropractic Board of Sports Physicians, International Chiropractors Association, Association for the History of Chiropractic, Counsel of Science Editors, American Public Health Association, Committee on Publication Ethics, World Association of Medical Editors, American Medical Writers Association, and American Educational Research Association.
Collaboration and Resources In the past, the chiropractic profession had been excluded from participation in national and international health care efforts, but recently, we have become more involved.17 We need to train and position doctors of chiropractic to collaborate with others, develop and implement effective health care policies, and become more involved within health care and decision-making system on local, national, and international levels. We need to join together as a unified profession and support CER efforts. These efforts may include collaborating with other organizations, supporting doctors of chiropractic to be included in EHR and other data-gathering bodies, developing a research network to build a CER infrastructure, conducting research to support CER, integrating CER findings into chiropractic clinical guidelines, and communicating CER results to stakeholders. We should work together to share resources, avoid unnecessary duplication of efforts, and increase communication between all stakeholders.
CONCLUSIONS The field of CER is evolving, and the chiropractic profession has the opportunity to be included. Current barriers threaten the inclusion of chiropractic; however, opportunities exist to solve these issues. These may include chiropractic groups participating with and contributing to the ongoing CER efforts, greater clarification and standardization of chiropractic procedures and records, create more opportunities for chiropractors to be included in the health care system, focus on long-term gain not short-term reimbursement, and working together in a unified research effort and developing an ongoing research agenda. By
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12. Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med 2009;22:62-8. 13. Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, et al. Expenditures and health status among adults with back and neck problems. JAMA 2008;99:656-64. 14. Fisher E, Goodman D, Skinner J, Bronner K. Health care spending, quality, and outcomes: more isn't always better; 2009. Retrieved on February 20, 2010, from www. dartmouthatlas.org/atlases/Spending_Brief_022709.pdf. 15. Congress of the United States Congressional Budget Office. Research on the comparative effectiveness of medical treatments: issues and options for an expanded federal role, Pub. No. 2975, December 2007. Retrieved on March 18, 2010 from https://www.ecri.org/Documents/CERC/CBO_12-18ComparativeEffectiveness.pdf. 16. Healthy People 2020. The secretary's advisory committee on national health promotion and disease prevention objectives for 2020: Phase I. 2008. Retrieved on February 20, 2010 from http://www.healthypeople.gov/hp2020/advisory/default.asp. 17. Johnson C, Baird R, Dougherty PE, Globe G, Green BN, Haneline M, et al. Chiropractic and public health: current state and future vision. J Manipulative Physiol Ther 2008;31: 397-410. 18. Hurwitz EL, Morgenstern H, Kominski GF, Yu F, Chiang LM. A randomized trial of chiropractic and medical care for patients with low back pain: eighteen-month follow-up outcomes from the UCLA low back pain study. Spine (Phila Pa 1976 2006;31:611-21. 19. Bronfort G, Haas M, Evans R, Kawchuk G, Dagenais S. Evidence-informed management of chronic low back pain with spinal manipulation and mobilization. Spine J 2008;8:213-25. 20. Hebert J, Koppenhaver S, Fritz J, Parent E. Clinical prediction for success of interventions for managing low back pain. Clin Sports Med 2008;27:463-79. 21. National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey, 2007-2008; 2007. Retrieved on February 20, 2010 from www.cdc.gov/nhanes. 22. Medical Expenditure Panel Survey (MEPS). Survey Background; 2006. Retrieved on February 20, 2010 from http:// www.meps.ahrq.gov/mepsweb/about_meps/survey_back.jsp. 23. Davis MA, Sirovich BE, Weeks WB. Utilization and expenditures on chiropractic care in the United States from 1997 to 2006. Health Serv Res 2009 Dec 4 (Epub ahead of print). 24. O'Carroll PW. Public health informatics and information systems. New York: Springer Verlag; 2003. 25. Fredericks M, Hang L, Ross MWV, Fredericks J, Lyons L. Chiropractic physicians: Toward a synthesis of electronic medical records and the society, culture, personality model in the new millennium. J Chiropr Humanit 2008;15:2-9.
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26. Dunn AS, Green BN, Gilford S. An analysis of the integration of chiropractic services within the United States military and veterans' health care systems. J Manipulative Physiol Ther 2009;32:749-57. 27. Goldberg CK, Green B, Moore J, Wyatt M, Boulanger L, Belnap B, et al. Integrated musculoskeletal rehabilitation care at a comprehensive combat and complex casualty care program. J Manipulative Physiol Ther 2009;32:781-91. 28. Crow WT, Willis DR. Estimating cost of care for patients with acute low back pain: a retrospective review of patient records. J Am Osteopath Assoc 2009;109:229-33. 29. Sarnat RL, Winterstein J, Cambron JA. Clinical utilization and cost outcomes from an integrative medicine independent physician association: an additional 3-year update. J Manipulative Physiol Ther 2007;30:263-9. 30. Grieves B, Menke JM, Pursel KJ. Cost minimization analysis of low back pain claims data for chiropractic vs medicine in a managed care organization. J Manipulative Physiol Ther 2009;32:734-9. 31. Sharma R, Haas M, Stano M, Spegman A, Gehring R. Determinants of costs and pain improvement for medical and chiropractic care of low back pain. J Manipulative Physiol Ther 2009;32:252-61. 32. Triano JJ. Literature syntheses for the Council on Chiropractic Guidelines and Practice Parameters: methodology. J Manipulative Physiol Ther 2008;31:645-50. 33. Globe GA, Morris CE, Whalen WM, Farabaugh RJ, Hawk C. Chiropractic management of low back disorders: report from a consensus process. J Manipulative Physiol Ther 2008;31: 651-8. 34. Lawrence DJ, Meeker W, Branson R, Bronfort G, Cates JR, Haas M, Haneline M, Micozzi M, Updyke W, Mootz R, Triano JJ, Hawk C. Chiropractic management of low back pain and low back-related leg complaints: a literature synthesis. J Manipulative Physiol Ther 2008;31:659-74. 35. Vernon H, Schneider M. Chiropractic management of myofascial trigger points and myofascial pain syndrome: a systematic review of the literature. J Manipulative Physiol Ther 2009;32:14-24. 36. Schneider M, Vernon H, Ko G, Lawson G, Perera J. Chiropractic management of fibromyalgia syndrome: a systematic review of the literature. J Manipulative Physiol Ther 2009;32:25-40. 37. Pfefer MT, Cooper SR, Uhl NL. Chiropractic management of tendinopathy: a literature synthesis. J Manipulative Physiol Ther 2009;32:41-52. 38. Brantingham JW, Globe G, Pollard H, Hicks M, Korporaal C, Hoskins W. Manipulative therapy for lower extremity conditions: expansion of literature review. J Manipulative Physiol Ther 2009;32:53-71.
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Claire Johnson, DC, MSEd
ABSTRACT The purpose of this article is to discuss comparative effectiveness research (CER) as it relates to the chiropractic profession. This article reviews CER priorities as determined by the Institute of Medicine and suggests actions for the chiropractic profession to become more involved in CER. (J Manipulative Physiol Ther 2010;33:243-250) Key Indexing Terms: Comparative Effective Research; Chiropractic Profession
n the United States, we are facing a health care crisis. Although there have been improvements in various medical and public health innovations, we are still experiencing increasing costs and disparities in services to portions of our population; not everyone has access to the health care that they need.1 Our population continues to age, and the average life expectancy continues to rise and we will observe growing costs associated with managing chronic conditions. As we struggle with health care reform, there are many obstacles that must be overcome to solve these problems. Thus, we are in search of clinically and cost-effective ways to best address the needs of individuals and populations. Although the information explosion from scientific research and the increased complexity of health care services seem to promise better health benefits, they have created a perplexing and costly maze for both patients and providers to navigate. At present, many people who seek care from one health care provider may not have coordinated care with other providers, which may result in duplication of services, or worse, adverse events that may harm patients' health. In this complicated environment, the concept of integrative health care (IHC) has evolved. Integrative health care is a cooperative model in which
I
Editor, JMPT, Professor, National University of Health Sciences, Lombard, Ill. Submit requests for reprints to: Claire Johnson, DC, MSEd, Editor, JMPT, Professor, National University of Health Sciences, 200 E. Roosevelt Rd, Lombard, IL 60148 (e-mail: [email protected]). 0161-4754/$36.00 Copyright © 2010 by National University of Health Sciences. doi:10.1016/j.jmpt.2010.04.001
health practices and practitioners coordinate together in the best interest of both patient and population health.2,3 In an IHC environment, it is important to select the most beneficial care for patients, avoid harmful treatments or side effects, and reduce costs. Thus, accurate and reliable information is needed when making health care decisions. Evidence-based practice (EBP) has promised to help address some of our health care information needs by using evidence to help clinical decision making. Evidence-based practice was first made popular in 1991 by Sackett and is the “conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patient.”4,5 However, as with any tool, there are limits to EBP, and therefore, additional solutions are being sought. For example, it is estimated that less than half of medical practices are founded on scientific evidence,6,7 and it is unknown what percentage of other health professions' practices (eg, nursing, physical therapy, chiropractic, acupuncture) are scientifically based. Evidence-based practice typically is not able to bridge the gap when little or insufficient evidence is present. Under the present conditions, it would not be possible for any health care provider to practice using an “evidence-only” method. Therefore, additional methods are needed to help practitioners select the best methods to meet the health care needs of their patients. Comparative effectiveness research (CER) may offer solutions to address some of these needs. Comparative effectiveness research includes the principles and methods of EBP in addition to other methods and offers solutions to the issues that EBP is not designed to cover. 1,7-10 Comparative effectiveness research incorporates findings from research, identifies health needs and information gaps, 243
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looks for ways to close these gaps, and then implements them in real-world practice settings.8,9 Comparative effectiveness research also includes other factors that are important when making health care decisions, such as costs, population characteristics, available treatments options, delivery methods, diagnoses, and health care environment (eg, data from real-life practice may be preferred over data that are collected in a controlled setting). One might say CER is the next step in the evolution of scientifically based health care. In February 2009, President Obama signed into law the American Recovery and Reinvestment Act. This act dedicated $1.1 billion dollars in funding for CER and additional funding for the Institute of Medicine (IOM) to make recommendations and set CER priorities.11 The focus of CER is to directly compare risks and benefits of different treatments for a particular condition, which will impact how clinical decisions are made. Although these efforts are not meant to mandate coverage or reimbursement,11 information from these research efforts are expected to change how the practice and business of health care are being done in the United States. Seeing these changes on the horizon, it would be crucial for the chiropractic profession to be included in these efforts. The purpose of this article is to provide a brief introduction to CER and how the chiropractic profession might become more involved.
DEFINING CER The IOM defines CER as follows: “the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.”7
The Federal Coordinating Council for Comparative Effectiveness Research provides the following definition: “Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in “real-world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.”8
Comparative effectiveness research promises to take the benefits of EBP and apply these and other attributes to population health.9 Whereas EBP focuses on applying critically appraised research to a clinically relevant question in the context of the best interest of the patient, CER additionally proposes to improve additional factors in health care at both patient and population levels.9 There are several motivations behind the CER movement in addition to improving patient care. One theme that
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recurs in CER literature is that CER may help to contain costs. For the past 10 years, health care costs in the United States have increased 2 and a half times the average of other similar countries.9 One might have expected that methodological and technological health care improvements that we have witnessed in the past decades would have reduced costs; however, these costs continue to rise. Both private and public spending for health care has increased, and federal spending on Medicare and Medicaid has tripled.9 Other concerns that have stimulated an interest in CER include the over use of treatments that may be harmful, not helpful to the patient, or simply a waste in spending. For example, Deyo et al12 found that although the Medicare population only increased by 12%, there was a 629% increase in Medicare costs for steroid injection for back pain. As well, through an analysis of National Medical Expenditure Panel Survey (MEPS) data, they found a 108% increase in opioid prescriptions and a 423% increase in costs for opioids for back pain.12 A study by Martin et al13 reviewed MEPS data from 1997 to 2005 to analyze expenditure and health outcomes. They found that in the United States there was an increase in spending for back and neck pain but without improvement in health outcomes. Another concern includes the variation in expenditures and quality of health care by geographic region. Fisher et al14 showed that in the United States, health care costs varied by region and higher costs did not necessarily correlate with better care or improved outcomes. Even when various factors were taken into consideration, such as cost of living and severity of illness, cost variation could not be accounted for. These facts lead us to ask if there are better ways to manage common conditions such as back pain and control costs of care. It is important to note that the United States is not the first to develop CER efforts. Other countries, such as the United Kingdom, Germany, France, Canada, Denmark, and Australia have programs already in place that evaluate cost and effectiveness of various health care methods.9,15 For example, the United Kingdom has the National Institute for Clinical Excellence that conducts systematic reviews on the cost-effectiveness of health care interventions. The National Health Service uses these reports to make health care coverage decisions in the United Kingdom. In Germany, the Institute for Quality and Efficiency in Health Care evaluates treatments and clinical practice guidelines. The Federal Joint Committee uses the Institute for Quality and Efficiency in Health Care reports to make health care coverage decisions in Germany. Therefore, if the United States were to follow the trend found in other countries, data and reports generated from CER would likely determine type of care allowed for a given condition and if the treatment would be covered.9,15 Comparative effectiveness research is not the only answer but one more way of looking at information to try to find better answers. Comparative effectiveness research
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compares various health care methods in a head-to-head fashion to inform decision makers about which type of care is more beneficial, is safer, and more cost-effective. Comparative effectiveness research focuses on evidence synthesis and systematic reviews in addition to other types of research designs. Once this information has been gathered and reviewed, new knowledge is developed or identified to fill information gaps. The final step is to communicate this knowledge to all the stakeholders such as patients, providers, payers, and policy makers. This last step, translation of research and knowledge into practice, must be accomplished if CER is to make a difference.
IOM SETS CER PRIORITIES
FOR THE
UNITED STATES
The American Recovery and Reinvestment Act of 2009 charged the IOM with conducting a study to determine research priorities for CER in the United States.7 The IOM crafted a list of priorities for CER through a labor-intensive process, which is summarized here. An ad hoc committee was created and solicited input in 3 ways. The first was to invite key stakeholders (eg, American Medical Association, Association of Schools of Public Health, Biotechnology Industry Organization, Blue Cross and Blue Shield Association, American Heart Association, National Pharmaceutical Council, and others) and the public to a conference to discuss issues of CER.7 The second was through the Internet using a Web-based nomination process to collect and establish priorities of the topics. The Web-based questionnaire collected 2606 topics from 1758 respondents. From this process, 1628 topics were selected to go on to prioritization. The third process included input from participants through the project's Web site. For the selected topics, the online questionnaire asked each respondent to support each nominated topic with specific information, include information to support the proposed research, suggest appropriate study populations, suggest what interventions might be compared, and propose research method.7 The next step created priority setting criteria. Two sets of criteria were used to evaluate each priority topic. The first was condition-level criteria (eg, burden of disease, prevalence, mortality, morbidity, cost, variability). The second was topic-level criteria (eg, appropriateness of the item, information gaps, use for decision making, risks associated with care, gaps in translation from research to practice). The committee used information from data bases such as from the Cochrane collaboration to determine existing research and MEPS data for information on cost, prevalence, and morbidity. After analyzing the information, the committee went through 3 rounds of voting to narrow down the list. The voting criteria included clinical category, study population, interventions, and research method. The resulting top 10 priority CER topics include the following
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areas: health care delivery, disparities, disabilities, cardiovascular, geriatrics, psychiatry, neurology, pediatrics, endocrinology, and musculoskeletal. After creating the priority-setting criteria, the IOM made recommendations to support CER. These recommendations included the following: prioritization of CER topics as a continuous process and the inclusion of input from all stakeholders, inclusion of public participation by using information from national data to identify diseases/conditions and research gaps, continued evaluation of prioritized topics through a quality improvement process, and regular reporting of research updates and findings through a federal organization to support databases and registries.7 The IOM committee also made recommendations about an infrastructure to maintain CER efforts, including the creation of an advisory body to help report on CER activities. It was suggested that the advisory body should include patients, providers, and researchers because each address health care from a different point of view. The committee recommended that the CER program develop new methods to address CER needs such as the use of observational data and development of more practically crafted clinical trials.7
IOM MUSCULOSKELETAL PRIORITIES One might ask if there is anything that the chiropractic profession could do to be more involved in CER. Because most of what we manage on a day-to-day basis is musculoskeletal in nature, it would make sense that this is one area that may be a good match. In the classification of CER priorities, IOM recognized that “musculoskeletal disorders” is a very broad topic. Therefore, they clarified the focus of this topic based upon Healthy People 2020 goals,16 which include neck/back pain and osteoarthritis. The criteria used to select these as priorities include that they are the most prevalent, costly, and morbid conditions. Areas for inquiry include establishing a registry to compare effectiveness of treatment strategies for low back pain, establishing a registry to compare effectiveness of surgical and nonsurgical methods for treating cervical spondylotic myelopathy, comparing effectiveness of treatment strategies for cervical disk and neck pain, comparing effectiveness of surgical strategies for patients in which nonsurgical care has failed, and comparing effectiveness of treatment strategies in the prevention of disability of osteoarthritis.7 Keeping these IOM priorities in mind, procedures or provider type that can influence these conditions should be included in future comparative analyses. This means that treatment from doctors of chiropractic or other styles of care for these conditions could be considered when developing CER strategies. Specifically 4 of the 5 priority topics could include nonsurgical and nonpharmaceutical interventions, which is a good fit for chiropractic care.
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It is estimated that more than $100 billion per year is spent in the United States on back pain.13 Chiropractors traditionally provide care to patients without the use of drugs or surgery,17 and evidence shows that chiropractic care can provide relief for back and neck pain conditions.18-20 As determined by the IOM, there is a priority for CER focusing on back and neck pain. There is also evidence that chiropractic is effective in managing back and neck pain, and chiropractic is an alternative treatment to surgical and pharmaceutical treatments. Therefore, it would make sense to include chiropractic as a treatment approach in the research agenda for CER.
POTENTIAL SOURCES FOR CER
OF
CHIROPRACTIC INFORMATION
National Health and Nutrition Examination Survey and MEPS Databases are available that could contribute to CER related to back pain and chiropractic care. The National Health and Nutrition Examination Survey collects information related to health and nutrition by survey and interview from American children and adults.21 The survey collects information about the prevalence of chronic conditions in addition to risk factors. Specific health conditions related to musculoskeletal conditions include osteoporosis, physical fitness, and physical function. The survey includes questions about medical and nonmedical providers seen, such as chiropractic, physical therapy, and osteopathy. In addition to the survey, a physical examination is performed by a medical physician. This information helps to identify the overall health of the population, what health conditions may be present, and what types of providers people are seeing. However, this information does not track treatment type or effectiveness with the specific condition a person may have. Nor does it measure treatment costs associated with these conditions. The MEPS is a part of the Agency for health care Research and Quality, a division of the US Department of Health and Human Services. Medical Expenditure Panel Survey is a set of large-scale surveys of families and individuals, their medical providers, and employers across the United States.22 This database can be accessed online, and various search strategies can be performed, including a search of chiropractic services. Other MEPS search categories include payer types including Medicare, federal, and private insurance payments. Although the MEPS information is important to track costs for expenditures of various provider types, this information does not necessarily connect to clinical outcomes. Questions that are not answered by these data are if the patients being seen by chiropractors are the same in age, complaint, severity, or income as those seeing other providers. The data do not inform us if the outcomes were similar, worse, or superior to other provider types for the same condition and severity.
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There is also no information about specific types of care offered by these services. There is a huge range of services offered by chiropractors, but it is not clear what is being provided in this database. Although there are not many published studies that describe chiropractic using MEPS, there are a few. In one example, Davis et al23 performed a study to investigate use and costs of chiropractic care between 1997 and 2006 using MEPS. They assessed the number of American adults who received chiropractic care, number of chiropractic visits, and used the inflation-adjusted costs. They found that the inflation-adjusted expenditures on chiropractic care increased from $3.8 to $5.9 billion; however, total expenditures per patient and office visit remained unchanged. On the basis of these findings, they concluded that the number of patients seeking chiropractic care has increased. Although this is not specifically a CER study, it demonstrates that evaluation of some chiropractic information can be completed and that further exploration of MEPS to answer CER questions may be fruitful.
Electronic Health Care Records Electronic Health Care Records (EHR) provide health care providers and public health service opportunities to improve processes.24 Electronic Health Care Records can be incorporated into decision support and expert systems to provide a framework for many functions. Electronic Health Care Records can collect information on individual patients as well as populations. Providers that are located in different areas but who are serving the same patient, such as with active duty military personnel, can easily access health records without having to wait for them to be sent in the mail. Coordination of services can be assisted by EHR by allowing health care coordinators to access care patterns and to make sure patients are being referred in a timely manner and that there are no duplication of services. For example, if a patient has recently received a magnetic resonance imaging scan on the area of complaint, there is no need to perform the scan again unless other factors warrant a repeat procedure. Electronic Health Care Records can also facilitate expert consultations from specialists who are not readily accessible due to geographic location. A health care provider at a rural location may be able to access a specialist from a distant location through the EHR. For example, by having digital imaging files stored in the health record, imaging experts can be consulted on the case and reports generated very quickly. Electronic Health Care Records can also assist providers with delivering care that is more in alignment with current health care guidelines.24 For example, programs can be set up so that well patient visits are included. The program can prompt the provider and the patient that certain activities such as health screenings may be needed at the next patient visit. If a checkup is needed,
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a reminder can be included with the patient's EHR. The EHR can also be used to track trends in health screening procedures. For example, the number of patients receiving mammograms at the recommended age for a high-risk subgroup of the population will help to direct the activities of the local public health services. Electronic Health Care Records are receiving more attention in the field of chiropractic.25 Fredricks et al25 suggest that chiropractors can use EHR to improve availability, accessibility, affordability, continuity, and quality especially as these relate to integration of chiropractic services within the larger health care system and IHC. Doctors of chiropractic are currently using EHR in two of the largest health systems in the US (ie, Department of Veterans Affairs and the Department of Defense).26 Electronic Health Care Records have been described as one method used to coordinate and facilitate integrated care in these environments.27 In these settings, the chiropractic provider enters all care notes into the HER and all other providers have access to these files. Patients can be more quickly directed to appropriate care, such as a patient with simple mechanical low back pain can be scheduled for a chiropractic visit instead of burdening the appointment waitlist for orthopedic surgery. There is hope that EHR will help to provide higher quality and more efficient care. However, the EHR system is not yet standardized across the United States, and not all locations have EHR systems. As these systems evolve and develop, more research can be achieved using EHR for CER. As one example of CER that can be performed using EHR, Crow and Willis28 performed a study that estimated costs for acute low back pain comparing standard care to manipulative treatment. This study reviewed the electronic medical records at one hospital in Florida for a period of 3 years. They compared a control group (receiving medical care) to those receiving manipulation and found a significant difference between the groups. The osteopathic group received significantly less diagnostic imaging (ie, 74% fewer radiographs and 90% fewer magnetic resonance imaging scans), and overall costs were lower by $38.26. Within an IHC system, communication, peer review, and monitoring of outcomes help to promote best practices. Electronic Health Care Records can provide a means for a variety of specialists and practitioners to communicate with each other and coordinate care. Electronic Health Care Records can also be used to track provider practices, such as in performance review, or track trends or effectiveness in treatment, diagnosis, and following established practice guidelines. Because information in EHR can be harvested, it is possible for data to be collected on outcomes for specific treatments, time to recovery, and quality of life measures. Another facet of health care is cost. Electronic Health Care Records can help to track practice patterns and provide information about costs of treatment for various conditions. This information can possibly be compared by
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region, by provider type, or treatment method.9 However, this information can only be compared and analyzed if it is entered into the system. Oftentimes chiropractic health care practices fall outside of the medical care system, may be practiced outside of a health care network, or are not included in an EHR. If chiropractic is not included in the EHR, information from these provider encounters will not be included in the data, and therefore, this section of the population will be invisible when it comes time for decision making in policy and health care practices. Thus, it is important to include chiropractic in EHR so that it may be included in the CER process.
Other Information Sources There are other potential sources that may be able to provide primary and secondary chiropractic information for inclusion in CER efforts. Information from insurance companies, third party payors, or institutions that are dedicated to collecting and evaluating this information may be helpful in contributing to the CER infrastructure. For example, Sarnat et al29 analyzed clinical and cost use data from an integrative medicine independent physician association whose primary care physicians were doctors of chiropractic. Information was analyzed for clinical use, cost, and satisfaction. They found that chiropractors in this organization using nonsurgical and nonpharmaceutical approaches demonstrated reductions in both clinical and cost use compared to using conventional medicine alone. In another example, Grieves et al30 performed a study that evaluated data from a managed care organization. They looked at differences in cost for managing low back pain by medical doctors compared to doctors of chiropractic in an integrated care environment. They found that chiropractic management was less expensive than medical management of low back pain when care extended beyond primary care and that primary care management alone for low back pain was indistinguishable from chiropractic management in costs. In a different study, Sharma et al31 evaluated practice-based research data for short-term and long-term determinants of costs and pain improvement for care of low back pain comparing treatment provided by medical doctors to doctors of chiropractic. Thus, primary data from various records, such as from practice-based research, independent physician associations, or managed care organizations, may provide helpful information to CER. As well, entities that focus on systematic reviews, such as the Cochrane Collaboration or the Agency for health care Research and Quality, have teams of people actively involved in finding and summarizing research information. These teams perform secondary CER studies using information from the literature. They gather information based upon a list of criteria then pool the information and analyze it to determine which procedures or methods are
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scientifically based and which are safe and/or clinically superior to another method.
OBSTACLES
FOR INCLUSION OF
CHIROPRACTIC
IN
CER
To support research efforts that will generate and synthesize evidence that compares benefits and harms of methods that will prevent, diagnose, and treat various conditions, a strong research infrastructure must be in place. There are several criteria for an item to be included in a national CER program. As described earlier, through the efforts of IOM, a need must be established to set a topic as a priority. It is interesting to note that no chiropractic-related groups were represented on the list of stakeholders named in the report.7 There may be several reasons for this lack of representation; however, a chiropractic voice representing conservative care for spinal conditions without the use of surgery or pharmaceuticals did not seem to be at the table. This suggests that there may be future opportunity for chiropractic groups to participate and contribute to the ongoing IOM CER efforts. The IOM priority topic of musculoskeletal conditions (eg, including back and neck pain and osteoarthritis) is a good match for chiropractic services. It would seem that a comparison of chiropractic services with other services would be relatively easy. However, in some situations, the coding system may be set up so that the only way that chiropractors may get reimbursed is to use a separate code from what other health care providers are using. The 739 International Classification of Diseases diagnosis code is for a “nonallopathic” lesion and is the code that most chiropractors use when billing or recording care. However, this code is not well defined, and other providers may also use this code with a different purpose in mind. This generates a problem when trying to compare 2 different treatments of a group of patients with like diagnoses. Treatment codes are also difficult to identify. For example, if a code used for chiropractic manipulation is required for reimbursement, however, no other adjunct procedures are recognized by the system, it may not provide the complete clinical picture. It is possible that these adjunct procedures are essential to patient improvement but might not be included in the database. Within the chiropractic profession, there are a great variety of styles of chiropractic manipulation. Thus, simply evaluating a code for “manipulation” is almost meaningless. This suggests that greater clarification and standardization of how chiropractic diagnoses and treatment procedures are recorded, especially in the EHR, are necessary. The research processes of CER will require the completion of systematic reviews. Thus, a complete and up-to-date knowledge/bibliographic database will be required. Once the current literature has been collected, group consensus processes will assess the findings, and best practice decisions will need to be made, such as what was
done by the Council on Chiropractic Guidelines and Practice Parameters.32-38 From these, information gaps will be identified, and a research agenda will be formed. While this agenda is being created, the type of research will be considered, such as if additional randomized controlled trials are needed or if population-based studies are more appropriate. Unless we have an entity in the chiropractic profession that is willing to support these ongoing efforts with skilled people and funding, performing these processes will not be possible. A few of the national databases that track expenditures include mention of chiropractic services but not necessarily in enough detail to determine important factors, such as cost benefit compared to other procedures, potential harm or adverse effects, and overall health outcomes of the patient receiving various types of care for neck or back pain. Although chiropractic care has been shown to be useful and safe for various conditions, many medical facilities do not include chiropractic services. If a health plan includes chiropractic care, these may be accessed off site and/or not included within the larger health care system. Many chiropractors work in solo or small group practices; thus, inclusion in EHR may be either nonexistent or slowly implemented, which causes a problem with being included in CER. When comparing costs, multiple health factors should be considered. These include improvement in function, reduction in pain, number of visits to the provider, and long-term outcomes (eg, does the patient stay well over time). These suggest that we need to work toward providing more opportunities for chiropractors to be integrated within the health care system and include more meaningful and transparent details about chiropractic services in the EHR.
SUGGESTIONS Whether we like it, what we do, how well we do it, and how much our services cost will be compared to other health care services and professions. These results may further strengthen the position of the chiropractic profession within the health care system or they may result in a devastating blow. How we respond to CER may determine our fate. The following list, though not all-inclusive, suggests several items for the chiropractic profession to consider.
Costs As a profession, we need to focus on what we can do to increase quality and keep costs down. Instead of trying to figure out how we can bill more per patient, we need to figure out how to get our patients better faster, in a safer manner, and for less cost than other competing methods. Although it may seem counterintuitive to some in private practice who are trying to make ends meet in these tough economic times, if we are able to control costs, the scientific evidence will show that chiropractic is the
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method of choice and we will be assured a place in the health care marketplace. However, if we continue to search for ways to increase our reimbursements per case, although this may be a short-term gain for a few individuals, it will result in excluding or even possibly eliminating chiropractic care from the health care system.
Research Agenda Establishing a functional, relevant, and responsible research agenda is essential to being included in CER. We need to better communicate so that each institution that conducts chiropractic research is coordinated with other institutions in their research efforts. Although there is some very interesting research being produced, it is unclear how these uncoordinated efforts may fit into daily practice or how they could contribute to CER. As well, it is important that our current and future researchers be well trained with skills that are relevant to CER so that they can become active participants.
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developing a strong research agenda, collaborating, and controlling costs, the chiropractic profession has the potential to participate actively in CER and to improve patient care outcomes.
FUNDING SOURCES AND POTENTIAL CONFLICTS OF INTEREST No funding was received for this article. Disclosure statement: Claire Johnson, DC, MSEd, is the editor of the JCM, a full-time professor at the National University of Health Sciences, peer review chair for the Association of Chiropractic Colleges, a board member of NCMIC, and a member of the American Chiropractic Association, American Chiropractic Board of Sports Physicians, International Chiropractors Association, Association for the History of Chiropractic, Counsel of Science Editors, American Public Health Association, Committee on Publication Ethics, World Association of Medical Editors, American Medical Writers Association, and American Educational Research Association.
Collaboration and Resources In the past, the chiropractic profession had been excluded from participation in national and international health care efforts, but recently, we have become more involved.17 We need to train and position doctors of chiropractic to collaborate with others, develop and implement effective health care policies, and become more involved within health care and decision-making system on local, national, and international levels. We need to join together as a unified profession and support CER efforts. These efforts may include collaborating with other organizations, supporting doctors of chiropractic to be included in EHR and other data-gathering bodies, developing a research network to build a CER infrastructure, conducting research to support CER, integrating CER findings into chiropractic clinical guidelines, and communicating CER results to stakeholders. We should work together to share resources, avoid unnecessary duplication of efforts, and increase communication between all stakeholders.
CONCLUSIONS The field of CER is evolving, and the chiropractic profession has the opportunity to be included. Current barriers threaten the inclusion of chiropractic; however, opportunities exist to solve these issues. These may include chiropractic groups participating with and contributing to the ongoing CER efforts, greater clarification and standardization of chiropractic procedures and records, create more opportunities for chiropractors to be included in the health care system, focus on long-term gain not short-term reimbursement, and working together in a unified research effort and developing an ongoing research agenda. By
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