Review of Clinical Guideline Methodology

In November 1989, Congress amended the Public Health Service Act to create the Agency for Health Care Policy and Research (AHCPR). In turn, AHCPR requested advice from the Institute of Medicine (IOM) about how the agency might approach their new and challenging responsibilities for practice guidelines. Currently, the AHCPR has transformed into the Agency for Healthcare Research and Quality (AHRQ), which maintains guidelines online, including links to the National Guideline Clearhinghouse (NGC) and to other guideline agencies and resources, including an annotated bibliography on guideline developement methodology.

One of the early results of the AHCPR effort was the report “Clinical Practice Guidelines: Directions for a New Program” (Field and Lohr, 1990). A major conclusion of this report was that clinical guidelines should be founded on eight key principles.

Occurring in parallel with government agency efforts on clinical guidelines, other efforts have been directed toward defining outcome-based competencies for healthcare. These efforts have resulted in a number of publications and guides. Recognizing that medicine is taking on a global face, the Institute for International Medical Education (IIME) has developed a body of work on Global Minimum Essential Requirements. This work is summarized in GMER Core Committee and Wojtczak and Schwarz (2000).

In an apparently coordinated effort with the Association of Medical Education in Europe AMEE, a number of papers have been published both in the journal Medical Teacher and as AMEE Guides. In particular, Harden (1999) introduces concepts of outcome-based education and Shumway and Harden (2003) introduce assessment of outcomes.

Also during this period, the Accreditation Council for Graduate Medical Education (ACGME) has created the Outcome Project, addressing outcome-based competency for physicians in the 21st century. A summary of the ACGME efforts on defining competency was published by Epstein and Hundert (2002) with an editorial comment by Leach (2002). The ACGME noted that standards for professional competence delineate key technical, cognitive, and emotional aspects of practice, including those that may not be measurable. They defined six areas of competence and some means of assessing them:

Several other agencies provide extensive guidance on the guidelines development process, with a considerable level of inter-knowledge existing between efforts. The Austrialian National Health and Medical Research Council (NHMRC) has developed a protocol to guide the creation and implementation of clinical guidelines (NHMRC, 1999). They have derived nine basic principles for developing guidelines.

Recently, NHMRC (2005), the NHMRC has released a document to inform external persons and bodies of the procedures to be followed in developing guidelines which are intended for submission to the NHMRC for approval. This document includes flow-charts summarizing the process. In the UK, the National Institute for Health and Clinical Excellence has developed a manual on the guidelines development process (NICE, 2006). The AGREE Collaboration (Appraisal of Guidelines Research and Evaluation) has created the AGREE Instrument ((AGREE, 2003) to help unify the approach to guideline creation and implementation across Europe. The Scottish Intercollegiate Guidelines Network (SIGN) also provides guidelines and, as one of their guidelines, maintains the "Guidelines Developer's Handbook" (SIGN, 2004). The introduction the the SIGN handbook contains concise flow-chart summaries of the guideline development process and life-cycle.

There are a significant number of individual papers from different domains of health practices. Shekelle et al. (1999) discuss guideline development to ensure desired patient outcomes, based on a combination of the literature about guideline development and the results of their combined experience in guideline development in North America and Britain. Their paper considers the five steps in the initial development of an evidence based guideline. Thomas (1999) describes the development, implementation, and appraisal of clinical practice guidelines for nursing. She notes that while, "most of the development and evaluation of clinical guidelines has occurred in the field of medicine, nurses are becoming more interested in the use of guidelines as one means of facilitating evidence-based practice". Eccles and Grimshaw (2004) provide a succinct review of criteria for guideline selection and presentation. Cognitive factors affecting group consensus in creating guidelines were investigated by Raine et al. (2004). They note that "the nominal group technique is a method of eliciting and aggregating judgments in a transparent and structured way. It can provide important information on levels of agreement between experts. However, conclusions can be at odds with the published literature. If they are, reasons need to be explicit". Grilli et al. (2000) raise concerns about the quality, reliability, and independence of practice guidelines created by specialty societies. They note that such guidelines often fail to follow accepted methodological criteria.

Writing from a chiropractic perspective, Mootz and Hansen (1999) have discussed the use and understanding of what they term clinical algorithms. We note that their use of algorithm differs from general scientific usage in which an algorithm is taken to be a procedural recipe that includes allowance for repetition and branches; in short, any definite procedure for solving a problem or performing a task, independent of its specific form of presentation. Mootz and Hansen's use of algorithm as a graphical format would more generally be taken as the presentation of an algorithm as a graphical flowchart. The more widely used terminology will be used here, to facilitate interdisciplinary understanding. This generalizes Mootz and Hansen's statement that 'algorithms' offer providers and health care administers a "sense of predictability and a systematic organization to case management" to be information dependent rather than specific to a graphical format. As a specific example, it would include capturing guidelines within the Guidelines Element Model (GEM). It generalizes the decision tree from a representation as a flowchart to a more general concept of a 'graph' as an abstract structure of interconnections.

Eisenberg et al. (2002) examined a number of issues related to credentialing of CAM providers, including massage providers. Several short articles by Parkman (2004a, b, c, d) discussed credentialing issues. All of the above are general considerations, lacking discussion of any specific outcomes for massage.

Studdert et al. (1998) presented insurance claim data for massage, chiropractic, and medicine. For the period of 1993-1996 reported for massage, the Studdert et al. data indicate average massage claims of 1.8 per 1000 insured per year and 0.79 per 1000 claims paid, with an average payment of about $6400. The breakdown of claims were 61% minor injuries, 6% injuries above minor, 14% sexual misconduct, and 19% as 'nonphysical' or 'other'. As a raw comparison, claims for chiropractic and medicine averaged 26 and 94 per 1000 per year, respectively. The rates reported for massage by Studdert et al. are supported by two separate review papers. Ernst (2003) and Grant (2003) looked at the extremely rare reports of harm from massage in the medical literature. The conclusions of both reviews are well characterized by Ernst's conclusion that while "massage is not entirely risk free, serious adverse events are probably true rarities." Batavia (2004) examined the state of massage contraindications, noting lack of agreement between sources and a general lack of ties to any original basis or paper.

Cohen and Eisenberg (2002) address malpractice liability issues associated with CAM provision. They base their discussion on a four-cell table based on independent determination of safety and efficacy. In this framework, the papers by Studdert et al. (1998), Ernst (2003), and Grant (2003) would indicate that efficacy for specific conditions and contexts will be the larger consideration for massage therapy, coupled with practitioner abilities for communication and working as part of a healthcare team. Cohen (2004) and Ernst et al. (2004) have looked at ethical issues arising within CAM provision.

A number of papers have examined the balance and paradox of combining objective evidence with other considerations of practice. Hundert and Epstein (2002) include communication skills and team skills within their definition of competence. Egnew (2005) explores, from a medical perspective, the issues of healing that transend the application of technique. These issues have also been explored by cardiologist Bernard Lown in a recent book. Weissman (2000) comments on two papers that he feels embody both sides of the medical coin. Welch (2000) discusses the teaching of evidence-based medicine. Branch (2000) discusses medical education and the ethics of caring. Hewitt-Taylor (2003) and Hewitt-Taylor (2004) looks at the definition and balance of evidence related to nursing care. In the conclusions of the latter paper she specifically notes this balance.

"Despite the benefits of clinical guidelines and care protocols,these have the potential to lead to inappropriate levels of standardisation in which individual client contexts and professional autonomy and judgement are impeded. … Clinical guidelines should be seen as general recommendations, not absolutes that must be followed in all situations. They are a part, not the entirety, of nursing care provision and should influence decision making in the presence of clinical expertise and the ability to assess and evaluate individual patient needs in the light of available resources."

References

AGREE, 2003. Appraisal of Guidelines for Research & Evaluation. AGREE Collaboration, <http://www.agreecollaboration.org/pdf/aitraining.pdf>.

Batavia, Mitchell. 2004. Contraindications for therapeutic massage — do sources agree? Journal of Bodywork and Movement Therapies 8(1): 48–57. doi: <http://dx.doi.org/doi:10.1016/S1360-8592%2803%2900084-6>.

Branch, W. T. 2000. The ethics of caring and medical education. Acad Med 75(2): 127–132. issn: 1040-2446, url: <http://academicmedicine.org/pt/re/acmed/abstract.00001888-200002000-00006.htm>

Cohen, Michael H., and David M. Eisenberg. 2002. Potential physician malpractice liability associated with complementary and integrative medical therapies. Ann Intern Med 136(8): 596. issn: 1539-3704, uri: <http://www.annals.org/cgi/content/abstract/136/8/596>.

Cohen, Michael H. 2004. Legal and ethical issues in complementary medicine: a United States perspective. Med J Aust 181(3): 168–169. issn: 0025-729X. url: <http://www.mja.com.au/public/issues/181_03_020804/coh10299_fm.html>.

Eccles, Martin P., and Jeremy M. Grimshaw. 2004. Selecting, presenting and delivering clinical guidelines: are there any "magic bullets"? . Med J Aust 180(6 Suppl): S52–S54. issn: 0025-729X, url: <http://www.mja.com.au/public/issues/180_06_150304/ecc10749_fm.html>.

Egnew, Thomas R. 2005. The Meaning Of Healing — Transcending Suffering. Annals of Family Medicine 3(3): 255–262. doi: <http://dx.doi.org/doi:10.1370/afm.313>.

Eisenberg, David M., Michael H. Cohen, Andrea Hrbek, Jonathan Grayzel, Maria I. Van Rompay, and Richard A. Cooper. 2002. Credentialing complementary and alternative medical providers. Ann Intern Med 137(12): 965–973. issn: 1539-3704, uri: <http://www.annals.org/cgi/content/abstract/137/12/965>.

Epstein, Ronald M., and Edward M. Hundert. 2002. Defining and assessing professional competence. JAMA 287(2): 226–235. issn: 0098-7484, uri: <http://jama.ama-assn.org/cgi/content/abstract/287/2/226>.

Ernst, E. 2003. The safety of massage therapy. Rheumatology (Oxford) 42(9): 1101–1106. issn: 1462-0324, doi: <http://dx.doi.org/doi:10.1093/rheumatology/keg306>.

Ernst, E., M. H. Cohen, and J. Stone. 2004. Ethical problems arising in evidence based complementary and alternative medicine. Journal of Medical Ethics 30(2): 156–159. url: <http://jme.bmjjournals.com/cgi/content/abstract/30/2/156>.

Field, Marilyn J. and Kathleen N. Lohr, Editors, 1990: Clinical Practice Guidelines: Directions for a New Program, Committee to Advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine, ISBN: 0-309-56001-2, available from the National Academies Press at: <http://www.nap.edu/catalog/1626.html>

GMER Core Committee. 2002. Global minimum essential requirements in medical education. Med Teach 24(2): 130–135. issn: 0142-159X, doi: <http://dx.doi.org/doi:10.1080/01421590220120731>, uri: <http://www.iime.org/documents/gmer.htm>.

Grant, Keith Eric. 2003. Massage safety — injuries reported in Medline relating to the practice of therapeutic massage--1965-2003. Journal of Bodywork and Movement Therapies 7(4): 207–212. doi: <http://dx.doi.org/doi:10.1016/S1360-8592%2803%2900043-3>.

Grilli, R., N. Magrini, A. Penna, G. Mura, and A. Liberati. 2000. Practice guidelines developed by specialty societies: the need for a critical appraisal. Lancet 355(9198): 103–106. issn: 0140-6736, doi: <http://dx.doi.org/10.1016/S0140-6736%2899%2902171-6>.

Harden, R. M. 1999. AMEE Guide No. 14 — Outcome-based education: Part 1-An introduction to outcome-based education. Medical Teacher 21: 7–14. doi: <http://dx.doi.org/doi:10.1080/01421599979969>.

Hewitt-Taylor, Jaqui. 2003. Reviewing evidence. Intensive and Critical Care Nursing 19(1): 43–49. doi: <http://dx.doi.org/10.1016/S0964-3397%2802%2900068-X>,

Hewitt-Taylor, Jaquelina. 2004. Clinical guidelines and care protocols. Intensive and Critical Care Nursing 20(1): 45–52. doi: <http://dx.doi.org/10.1016/j.iccn.2003.08.002>

Leach, David C., 2002. Competence is a Habit. JAMA, 287(2): 243-244, <http://jama.ama-assn.org/cgi/content/extract/287/2/243>.

Lown, Bernard, M.D., 1999. The Lost Art of Healing, Ballantine Books, ISBN 0-345-42597-9. Reviewed by D J Weatherall, 1997: BMJ, 315:755 <http://bmj.bmjjournals.com/cgi/content/full/315/7110/755>

Mootz, Robert D. and Daniel T Hansen, 1999. Understanding and Appropriate Use of Clinical Algorithms, in Chiropractic Care of Special Populations, Jones & Bartlett, ISBN 0-834-21374-5, <http://www.jbpub.com/catalog/0834213745/>.

NHMRC, 1999. A guide to the development, evaluation and implementation of clinical practice guidelines. National Health and Medical Research Council, Australia, <http://www.nhmrc.gov.au/publications/_files/cp30.pdf> (see also <http://www.nhmrc.gov.au/publications/synopses/cp30syn.htm>).

NHMRC, 2005. NHMRC Standards and Procedures for Externally Developed Guidelines. National Health and Medical Research Council, Australia, <http://www.nhmrc.gov.au/publications/_files/nh56.pdf>.

NICE, 2006. The guidelines manual. National Institute for Health and Clinical Excellence, London. <http://www.nice.org.uk/page.aspx?o=guidelinesmanual>

Parkman, Cynthia A. 2004. CAM's struggle for legitimacy. The Case Manager 15(1): 22–24. issn: 10619259. url: <http://linkinghub.elsevier.com/retrieve/pii/s1061925903002777>.

Parkman, Cynthia A. 2004. Issues in credentialing CAM providers. Case Manager 15(4): 24–27. issn: 10619259. url: <http://linkinghub.elsevier.com/retrieve/pii/s1061925904001250>.

Parkman, Cynthia A. 2004. Initiatives for credentialing CAM practitioners Case Manager 15(5): 19–21+72. issn: 10619259. url: <http://linkinghub.elsevier.com/retrieve/pii/s1061925904001663>.

Parkman, Cynthia A. 2004. Regulatory issues in CAM Case Manager 15(6): 26–29. issn: 10619259. url: <http://linkinghub.elsevier.com/retrieve/pii/s1061925904001882>.

Raine, Rosalind, Colin Sanderson, Andrew Hutchings, Simon Carter, Kirsten Larkin, and Nick Black. 2004. An experimental study of determinants of group judgments in clinical guideline development. Lancet 364(9432): 429–437. issn: 1474-547X, doi: <http://dx.doi.org/doi:10.1016/S0140-6736%2804%2916766-4>.

SIGN, 2004. SIGN 50: A Guideline Developer's Handbook. Scottish Intercollegiate Guidelines Network, <http://www.sign.ac.uk/guidelines/fulltext/50/index.html>

Shekelle, Paul G., Steven H. Woolf, Martin Eccles, and Jeremy Grimshaw. 1999. Clinical guidelines — Developing guidelines, BMJ 318(7183): 593–596. url: <http://bmj.bmjjournals.com/cgi/content/extract/318/7183/593>.

Shumway, J. M., and R. M. Harden. 2003. AMEE Guide No. 25: The assessment of learning outcomes for the competent and reflective physician. Med Teach 25(6): 569–584. issn: 0142-159X, doi: <http://dx.doi.org/doi:10.1080/0142159032000151907>.

Studdert, D. M., D. M. Eisenberg, F. H. Miller, D. A. Curto, T. J. Kaptchuk, and T. A. Brennan. 1998. Medical malpractice implications of alternative medicine. JAMA 280(18): 1610–1615. issn: 0098-7484, uri: -<http://jama.ama-assn.org/cgi/content/abstract/280/18/1610.

Thomas, Lois. 1999. Clinical practice guidelines. Evidence-Based Nursing 2(2): 38–39. url: <http://ebn.bmjjournals.com/cgi/content/extract/2/2/38>.

Weissman, S. H. 2000. The need to teach a wider, more complex view of "evidence". Acad Med 75(10): 957–958. issn: 1040-2446, url: <http://academicmedicine.org/pt/re/acmed/abstract.00001888-200010000-00002.htm>.

Welch, H. G., and J. D. Lurie. 2000. Teaching evidence-based medicine: caveats and challenges. Acad Med 75(3): 235–240. issn: 1040-2446, url: <http://academicmedicine.org/pt/re/acmed/abstract.00001888-200003000-00010.htm>.

Wojtczak, Andrzej, and M. Roy Schwarz. 2000. Minimum essential requirements and standards in medical education. Medical Teacher 22: 555–559. doi: http://dx.doi.org/doi:10.1080/01421590050175514, url: http://www.iime.org/documents/vs.htm.