| Clinical Guidelines for Chiropractic Practice in Canada
Chapter 16 - Guidelines for the Development and Implementation of Practice Guidelines
Chapter Outline
I OVERVIEW
The purpose of this chapter is to make recommendations, based on the research in the field of guideline development and implementation, for methods of establishing, distributing, and evaluating guidelines for quality care in the practice of chiropractic. The foundation for guidelines must be sound methodology, explicitness and consistency with the scientific evidence.
Valuable resources in the development of this chapter have been the proceedings of the Mercy Center Consensus Conference in the United States (Haldeman et al. 1993) and the various publications of the RAND Corporation, the American Agency for Health Care Policy and Research (AHCPR) - the federal US agency charged with responsibility for development and implementation of practice guidelines in the health professions, and the Consortium for Chiropractic Research (CCR) - currently the leading agency in the chiropractic profession promoting the study, research, development and utilization of practice guidelines.
II DEFINITIONS
For definitions see the Glossary at the end of this publication.
Accuracy
Case Control Study
Clinical Guidelines
Cohort
Cohort Study
Cross Sectional Study
Discriminability
False-Negative rate (FNR)
False-Positive rate (FPR)
Gold Standard
Guidelines
Incidence
Likelihood Ratio
Likelihood Ratio for a (+) Test Result
Likelihood Ratio for a (-) Result
Meta Analysis
Natural History
Negative Test Result
Odds
Positive Test Result
Post-test Probability
Practice Guidelines
Precision
Predictive Value Negative
Predictive Value Positive
Pre-test Probability
Prevalence
Probability
Randomized Trial (Randomized Controlled Trial, Randomized Clinical Trial (RCT)
Reliability
Sensitivity
Specificity
Standards
True-positive Rate
True-negative Rate
Validity
III. LIST OF SUB-TOPICS
A. Establishing guidelines
B. Distribution of guidelines
C. Evaluation of guidelines
IV LITERATURE REVIEW AND DISCUSSION
Introduction
Over the last twenty years the North American health care industry has become more proactive in the development of quality assurance programmes and standards of practice. This has led to the development and implementation of measures to assure the delivery of quality care and to control increases in health costs. With the recent increases in public and scientific acceptance of chiropractic there is a need for the profession to move forward toward greater professional accountability by defining and distributing quality assurance and practice guidelines.
Recently a body of evidence has emerged suggesting a wide variation in chiropractic practice. Shekelle and Brook (1991) documented a sevenfold difference in frequency of chiropractic patient visits between identified geographic locations in the U.S. It is clear that chiropractic is not the only health care discipline with observed variations in the use of health care services (Chassin et al. 1986). However, there is additional evidence that the observed differences in utilization were behavioral rather than due to differences in population based on location. A study done in Washington showed that utilization and practice variation decreased significantly when the profession was aware that it was being studied (Hansen 1991). The chiropractic profession has acknowledged the evidence for variations in the type and frequency of care found in practice. One of the fundamental goals of establishing and using practice guidelines is to reduce variations in practice to facilitate the utilization of chiropractic care.
In the United States the Agency for Health Care Policy and Research (AHCPR) has provided definitions for standards of practice and quality assurance for health care professions. Unfortunately, when the "quality" of health care is judged in terms of cost or frequency of care the judgement tools or parameters might overlook the "quality of patient care". Quality in health care must include measures of excellence in patient care and favourable health outcomes (Chassin 1988). "Quality" of care is assured by professional competency, assessment of technology and professional adherence to standards. "Quality of patient care" is assured by outcomes assessment. Other measurements of quality of patient care include access to care, length of wait before receiving care, patient involvement in the health care decision making and patient satisfaction (Berwick & Knapp 1987).
In the field of chiropractic, practice guidelines are systematically developed statements to help chiropractors make educated clinical decisions about diagnostic methods and treatment interventions that will ultimately benefit the patients that seek this type of care. Interested groups outside the profession of chiropractic, such as insurance companies, governments and consumer groups, can use the guidelines to make informed decisions on behalf of their clients or constituents.
Standards of quality or standards of care are authoritative statements of minimal levels of acceptable performance or results, or excellent levels of performance or results, or the range of acceptable performance.
The guidelines can also serve to direct the research efforts of the chiropractic profession by ranking the needs for chiropractic clinical research.
Ongoing research into the development and distribution of practice guidelines and quality assurance will enable the chiropractic profession to improve quality of care and fulfil its obligations as an established primary health care profession.
A. Establishing Guidelines
Guidelines for chiropractic quality assurance and standards of care are based on a foundation of explicitness and scientific method (Guillain 1993). Specific attributes for guidelines in health care were established by the U.S. Agency of Health Care Policy and Research (AHCPR) and the American Institute of Medicine of the National Academy of Science in 1990 (Institute of Medicine 1990). These attributes include explicitness, validity, reliability/reproducibility, clinical applicability, clinical flexibility, clarity, multidisciplinary process and scheduled review. In 1991, the Consortium for Chiropractic Research issued a statement called Attributes of Chiropractic Practice Guidelines. This statement used the attributes established by the American Institute of Health, adapting them to the particular needs of the chiropractic profession. It is discussed later in this chapter under the heading Attributes of Guidelines.
The process of developing practice guidelines, including development, dissemination and use is one that requires a centralized chiropractic authority (Hansen et al. 1992). A structure for the development of chiropractic guideline development can be seen in Appendix A. The underlying premise for the development of such a structure is that the chiropractic profession will benefit from one common authority to oversee processes related to practice standards and guideline development. Selection criteria for commissioned panel members have been proposed (Hansen et al. 1992). Guidelines are developed using a universally accepted method of a) scientific validation, after reviewing the available scientific literature, b) clinical judgement, the views of experienced clinicians, and finally, c) consensus, in which a group of chiropractors representing the profession, and where appropriate representatives of the public and other disciplines, make decisions about recommendations based on scientific evidence and expert clinical opinion.
Weighing the Evidence
Specific recommendations for practice guidelines are based on the strength of existing scientific evidence, partly on expert clinical opinion. What follows is a discussion of the evaluation of existing scientific evidence. The randomized controlled clinical trial (RCT) is accepted as the best evidence, and the most reliable method, for deciding the relative merits of different treatments (Forbes 1981). However, the science of chiropractic is young and RCTs are lacking in most areas. When information from RCTs is not available, data from other less rigorously controlled studies may be helpful. Prospective, longitudinal (cohort) studies can provide a data base for computing relative risk. Case control studies can be useful in determination of odds' ratios. Case studies can serve as indicators of topics worthy of further study but cannot be used to imply cause-effect. A ranking of the methods for deciding the quality of published clinical literature is illustrated in Table 1 in Appendix B.
The scientific evidence for chiropractic intervention is located in the chiropractic and related literature. There are many methods available to assess this literature. These include the traditional literature review, meta-analysis and best evidence synthesis. The traditional literature review is used most often. Criteria for including studies in such a review are often poorly specified and statistical significance is frequently the only criterion for assessing treatment effects (Slavin 1986). If well-controlled clinical experiments are lacking a method of data synthesis or pooling, called meta-analysis, has been developed to arrive at summary conclusions (Glass 1976). This method pools the results of several smaller studies to make summary conclusions about diagnostic tests or therapeutic interventions. There are many methods of meta-analysis ranging from pooling results to pooling raw data (Light & Pillemer 1984). There are several meta-analyses of the effectiveness of spinal manipulative therapy for low-back pain.
Recently, meta-analysis has been criticized as a method of synthesizing data and coming to summary conclusions (Slavin 1986). A method called "best evidence synthesis" is theoretically superior to meta-analysis. Best evidence synthesis combines quantification of effect sizes, a priori inclusion criteria and attention to individual study methodological and procedural issues, including internal and external validity, in a full discussion of the body of literature being reviewed. The best evidence synthesis method, arguably the best way to assess a body of scientific literature, assumes that there exist studies that can withstand the imposed rigorous tests of inclusion for synthesis. The body of chiropractic and related literature has yet to reach this stage of development.
Accessing the Literature
Reviewing the chiropractic literature can be a formidable task for the chiropractic and non-chiropractic clinician or researcher. The Journal of Manipulative and Physiological Therapeutics (JMPT) is the only chiropractic journal with Index Medicus (CRJEC 1992) or international indexing status (Lawrence 1992). One of the elements considered by international indexing services when a journal applies for indexing, besides scientific quality, is audience. Only 0.2% of regular Index Medicus users are chiropractors (Lawrence 1992). A reason given by international indexing services for rejection of chiropractic journals, is that chiropractors do not cite their own literature or appear to use a data base sufficiently frequently (Lawrence 1992).
The present problems in accessing and retrieving chiropractic and associated literature are evident even in the area of manipulative therapy for low-back pain (Rupert 1992). Perhaps more chiropractors, and others, would use an international indexing service and data base if one was available to them. An international, computerized chiropractic data base and retrieval system, using standardized indexing terms, would allow chiropractors and others to reach the scientific literature within chiropractic. However, the universal use of standard indexing terms is a problem in chiropractic. Fortunately there are new information retrieval technologies, in various stages of development, that do not rely on key words (Hersh & Greenes 1990).
Developing Guidelines - Scientific Evidence and Consensus
A significant problem, in reviewing and synthesizing the results of clinical trials, is discriminating between statistical significance and clinical importance. Clinically useful outcomes might not be apparent in traditional reviews of the literature for a variety of reasons. Perhaps the available studies are poorly designed, uncontrolled, have obvious biases, poorly analyzed data, too few subjects or the subjects are not a representative sample of the target population (see Appendix C). Conducting a state-of-the art RCT of a physical treatment method such as spinal manipulative therapy requires enormous assets in terms of money, technical resources and expertise. However, elements of random and systematic error creep into even the most eloquent RCTs. Furthermore, conclusions are based on probability and arbitrary definitions of chance for a sample of subjects that are presumed to represent a usual mix of those in the population with the condition under study. There is infinite variability between patients, and the patients in one's practice may not be represented by the group of studied subjects (Shekelle 1992).
It is for these recognized reasons that expert clinical opinion, along with scientific analysis of available published clinical and basic science material, has been proposed as one of the preliminary steps, to occur before the consensus process, for developing guidelines for chiropractic practice. Combining the scientific approach to data synthesis, together with the opinions of experienced chiropractors engaged in day-to-day practice, is the appropriate means to bridge the present gap between science and clinical practice (Jamison 1984, Guillain 1993). It is being used in all areas of health care to produce evidence that delivered care is safe, efficient and effective (Shekelle 1993).
Finally, it is critical that the chiropractic profession develops valid assessment instruments including physiological and psychological measurement methods and tools (Coulter 1992). Without these instruments it is not possible to evaluate chiropractic assessment, diagnostic or therapeutic methods and protocols scientifically .
Attributes of Guidelines
The attributes of practice guidelines, developed by the Consortium for Chiropractic Research in 1991, can be applied to any effort in chiropractic guideline development to ensure high levels of accountability (see Appendix D). Clearly defined are who should develop chiropractic guidelines, the developmental process, and when guidelines should be evaluated. If chiropractic guidelines have these attributes they will be accepted as valid by all interested parties, who include not only chiropractors but also patients, other health professionals, and public and private third party payors.
B. Distribution of Guidelines
The single greatest task facing any health profession with respect to practice guidelines is not development, but rather dissemination of the guidelines in a way that will promote and bring guideline acceptance, implementation and use by professionals governed by the guidelines - here practising chiropractors.
Distribution of guidelines is an important first step in guideline use, but distribution by itself is not sufficient to alter clinical practice (Kosecoff et al. 1991). Furthermore, it is estimated that direct mailing of the document to the practitioner population only increases awareness of the consensus statement to the level of approximately 40% of practitioners (Jacoby & Clark 1986). Therefore, mailout distribution is not enough. Even with increased awareness, a consequent change in health care provider attitudes and behaviour might not occur.
Distribution strategies should be addressed not only at increasing awareness but also at influencing attitudes, knowledge and behaviour (Lomas 1991). Regarding the practice of chiropractic a survey of American chiropractors was conducted to determine the dominant attitudes and opinions of the profession toward practice standards and the organizations that developed them. Jansen, (1991) conducted a survey of American chiropractors to determine the dominant attitudes and opinions of the profession towards practice standards and the organizations that develop them. The survey was co-funded by Foundation for Chiropractic Education and Research and the Consortium for Chiropractic Research. The results of a factor analysis of responses to a mailout questionnaire suggest that the chiropractic profession is one composed of individual thinkers. Coherent factions within the profession account for only a small proportion of the total group. The conclusion of this study was that it would be difficult if not impossible to effectively address the entire profession with a single communication approach, and that to attempt to do so would not be wise. Basic approaches of implementation, after effective distribution, include education, feedback, incentives (financial and nonfinancial), administrative restrictions, sanctions and changing patient behaviour (Mittman & Siu 1991).
There is a growing body of knowledge in the area of practice parameters and use of practice guidelines, the discussion of which is beyond the scope of this chapter. However, knowledge of this is critical to the distribution of guidelines and cannot be ignored if widespread implementation of guidelines is to occur. Distribution must draw on the different fields of communication and information theory, commercial education, social and behavioral psychology, education, computer sciences and policy sciences (AHCPR 1991). Distribution of health care information, practice parameters, or guidelines is a difficult challenge with a growing body of sophisticated knowledge that will likely soon emerge as a discipline unto itself. As the body of clinical, administrative and policy-making information grows, the importance of the distribution of new information and practice guidelines and will become increasingly important so the health care practitioner can keep abreast of changes in the system that directly affect chiropractic practice and patients.
C. Evaluation of Guidelines
Helping health care providers and health care consumers to make informed decisions is different from evaluating practice. Informed decisions about health care are made through the review of practice guidelines. (Guillain 1993) Evaluating practice is done through review of practice patterns according to chiropractic review criteria, standards of quality care and performance measures.
Performance measures are methods or instruments that estimate the extent to which the actions of a health care provider conform to accepted levels of practice and review criteria. The measurement of chiropractor and payer compliance to established practice standards and guidelines requires careful and critical study. Such investigations typically reveal important issues about the attitudes and behaviour of the users of our increasingly structured health care delivery system. This kind of future endeavour, in which use of guidelines and standards of practice are studied via measurement of the compliance of the health care provider, is a critical part of chiropractic's entry into the era of health care accountability (Hansen et al. 1992). The chiropractic profession needs to develop specific methods of deriving practice evaluation tools. More investigation is needed into guideline implementation strategies and measurement of compliance.
V. ASSESSMENT CRITERIA
Rating Systems 2 assessment criteria are used in this chapter. For an explanation of this system see the Introduction and Guide to Use (p. xxiii).
VI. RECOMMENDATIONS (GUIDELINES)
A. Establishing guidelines
16.1 A standing committee should be formed to develop a national program agenda for development, dissemination and review of guidelines for chiropractic quality of care.
Rating: Necessary
Evidence: Class II, III
Consensus level: 1
16.2 New or revised guidelines should be developed using standardized methods of scientific validation and conform to the attributes of chiropractic guidelines for quality care published in 1991 by the Consortium for Chiropractic Research.
Rating: Necessary
Evidence: Class II
Consensus level: 1
16.3 The two uniform assessment criteria rating systems (rating systems I and II) used in this document should be adopted for subsequent revisions of procedure ratings or additions to the guidelines for chiropractic practice in Canada.
Rating: Necessary
Evidence: Class II
Consensus level: 1
16.4 The profession and its representative organizations should be encouraged to provide financial support to the Chiropractic Foundation for Spinal Research and registered chiropractic provincial research organizations. Research funded by these organizations should be done by chiropractors and other researchers, and should include:
a) clinical research;
b) guidelines for quality care; and,
c) development of valid and reliable instruments to assess new and existing chiropractic techniques and protocols.
Rating: Necessary
Evidence: Class II
Consensus level: 1
B. Distribution of Guidelines
16.5 The document in its final form should be distributed to each chiropractor in Canada as well as provincial and national chiropractic organizations.
Rating: Necessary
Evidence: Class II
Consensus level: 1
16.6 A committee with appropriate expertise should be formed to research and put into action appropriate methods of guideline distribution and implementation.
Rating: Necessary
Evidence: Class II
Consensus level: 1
16.7 All literature that addresses the development and use of guidelines, or is referenced by any of the chapters of this Canadian Chiropractic Association Guidelines document, including literature on consensus methods, should be included in a computerized data base and retrieval system.
Rating: Necessary
Evidence: Class III
Consensus level: 1
16.8 The contents of the chapter on chiropractic terminology/glossary should be published in the Journal of the Canadian Chiropractic Association.
Rating: Recommended
Evidence: Class III
Consensus level: 1
C. Evaluation of guidelines
16.9 Practice guidelines should be subject to scheduled review as decided by the proposed standing committee.
Rating: Necessary
Evidence: Class III
Consensus level: 1
16.10 An independent committee or agency should be appointed to study the attitudes toward and compliance with practice guidelines including baseline and follow-up studies.
Rating: Necessary
Evidence: Class II
Consensus level: 1
VII. COMMENTS, SUMMARY OR CONCLUSION
"Don't attempt to maintain self respect by maintaining self deception. Chiropractic facts must not be buried by the embellishment of philosophy." Joseph Janse DC. (Vear 1991).
The developing health care climate in anada is such that the chiropractic profession must invest ongoing increased effort and money in clinical research to be able to cite scientific evidence as the basis for chiropractic intervention. Those interested in chiropractic research must be able to produce high-level research and publish their findings in respected journals. Currently this will require funding through assessment of CCA members.
Professional isolation in chiropractic, from undergraduate education in private colleges to isolation in professional practice, is detrimental to the chiropractic profession in many ways, not the least being:
a) clinical isolation in undergraduate clinical education.
b) research isolation due to the excessive demands placed on members of the profession to subsidize private schools when those moneys could be put to use financing research.
c) the lack of a structured postgraduate education for professional members and those who wish to follow an academic or teaching career.
Furthermore, there is territorial isolation within chiropractic imposed by distinct differences between the 10 Canadian provincial and 52 U.S. state chiropractic acts. For example there are no common definitions for the terms "subluxation", "adjustment" and "manipulation" (Vear 1991). There are chiropractors who believe that these obvious problems of clinical and philosophical diversity within chiropractic cannot be solved until Canadian chiropractic colleges gain university affiliation.
There must be an ongoing effort to develop, update, distribute and implement practice guidelines and standards of quality. In the future it is likely that the research into and development of practice guidelines will be less reliant upon consensus and founded more upon structured critical debate (Coulter 1992). Now is the time to move toward intellectual debate based on conceptual analysis and construct validity, and away from anecdotal argument based on belief systems.
Finally chiropractic, as a profession, must conduct research to facilitate the implementation of its own established practice guidelines and standards. This research must include development of effective means of dissemination and measures of compliance.
VIII. REFERENCES
Agency for Health Care Policy and Research. Annotated Bibliography.
Effective Dissemination to Health Care Practitioners and Policy-makers. U.S. Department of Health and Human Services. Public Health Service. AHCPR Pub. No 92-0030. Nov. 1991.
Berwick DM, Knapp MG. Theory and practice for measuring health care quality. Health Care Finan Rev 1987; (49 Suppl).
Chassin MR. Standards of care in Medicine. Inquiry. 1988; 25:437-453.
Chassin MR, et al. Variations in the use of medical and surgical services by the medicare population. N Eng J Med 1986; 314:285-290.
Bergman et al. Chiropractic Research Journal Editors' Council. Report from the second annual meeting of the chiropractic research journal editors' council. J Manipulative Physiol Ther 1992; 15:1-3.
Coulter I. Consensus-too much of a good thing. Chiropractic Technique 1992; 4:19-20.
Forbes JF. Highlights in the development of randomized clinical trials. Med J Aust 1981; 1:159-160.
Guillain H. The agency for health care policy and research and the development of clinical practice guidelines: The importance of the consensus process in the development of national health care policy. Guidelines for Chiropractic Quality Assurance and Practice Parameters: Proceedings of the Mercy Center Consensus Conference; 1992 Jan 25-30; Burlingame. Gaithersburg: Aspen Publishers, 1993; xxv-xxviii.
Glass GV. Primary, secondary and meta-analysis of research. Educational Res 1976; 5:3-8.
Hansen DT. Chiropractic physician's practice patterns: A case study. Proceedings of the International Conference on Spinal Manipulation; 1991 April 12-13; Washington. Arlington: Foundation for Chiropractic Education and Research, 1991:255-257.
Hansen DT. Current efforts in chiropractic quality assurance and standards of care. J Can Chiropr Assoc 1991; 35:206-214.
Hersh WR, Greenes RA. Information retrieval in medicine: state of the art. M.D. Computing 1990; 7:302-311.
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Jacoby I, Clark SM. Direct mailing as a means of disseminating NIH consensus statements: A comparison with current techniques. JAMA 1986; 255:1328-1330.
Jamison JR. Educational preparation for chiropractic clinical research. J Manipulative Physiol Ther 1984; 7:109-117.
Jansen RD. A survey of American chiropractors' attitudes toward practice standards and the organizations developing them. Foundation for Chiropractic Education and Research. Grant #90-3-8. September 1991.
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Kosecoff J, Kanouse DE, Rogers WH, McCloskey L, Monroe Winslow C, Brook RH. Effects of national institutes of health consensus development program of physician practice. JAMA 1991; 265:2202-2207.
Lawrence D. Publish or Perish. J Can Chiropr Assoc 1992; 36:228-230.
Lawrence D. Journal Citation Tracking and Journal Indexing. Editorial. J Manipulative Physiol Ther 1992; 15:415-417.
Light RJ, Pillemer DB. Summing up: the science of reviewing research. Harvard Cambridge MA: University Press, 1984.
Lomas J. Words without action? the production, dissemination and impact of consensus recommendations. Ann Rev Publ Health 1991; 12:54.
Mittman BS, Siu AL. Changing provider behavior: Applying research on outcomes and effectiveness in health care. Improving Health Policy and Management: Nine Critical Research Issues for the 1990's. Ann Arbor: Health Administration Press, 1992.
Rupert R. A meta-analysis of clinical trials of spinal manipulation. Letter to the editor. J Manipulative Physiol Ther 1992; 15:477-478.
Sackett DL, Haynes RB, Tugwell P. Clinical Epidemiology: A Basic Science for Clinical Medicine. Toronto: Little, Brown & Co, 1985.
Shekelle P. The evolution and mechanics of a consensus process. Guidelines For Chiropractic Quality Assurance and Practice Parameters: Proceedings of the Mercy Center Consensus Conference; 1992 Jan 25-30; Burlingame. Gaithersburg: Aspen Publishers Inc., 1993; xxxix.
Shekelle PG, Brook RH. A community-based study of the use of chiropractic services. Am J Public Health 1991; 81:439-442.
Slavin RE. Best evidence synthesis: An alternative to meta-analysis and traditional reviews. Educational Researcher 1986; 15:5-11.
Vear HJ. Quality Assurance: standards of care and ethical practice. J Can Chiropr Assoc 1991; 35:215-220.
IX. MINORITY OPINIONS
None
APPENDIX A.
Chapter 16 - Appendix A
APPENDIX B.
APPENDIX C.
APPENDIX D. |