Volume 61, Number 3 - Summer 2010

 

By John Toton, MD

Wikipedia defines a clinical guideline as “a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of health care.” While noting that previous clinical guidelines were often based on tradition or authority, the definition further states that “modern medical guidelines are based on an examination of current evidence within the paradigm of evidence-based medicine.” Unlike “clinical pathways,” guidelines do not stipulate a process and are not intended to obstruct individualized treatment. 

Physicians rightly fear the perception that health insurers, spurred by federal health reforms, will establish rigid and arbitrary clinical pathways that will box in the physician’s ability to treat the individual patient. But if one carefully scrutinizes the definition above, perhaps an “evidence-based guideline” should not intimidate.

The cost of care has escalated beyond sustainable levels, and guidelines are in our future, if only to contain costs. If there were responsible guidelines based on real, verifiable medical evidence, physicians and patients would probably welcome their use. One might also hope that guideline-based care would improve treatment results, lessen patient morbidity, engender patient trust, and protect the physician from legal action.

As a member of the North American Spine Society (NASS) Evidence-Based Guidelines Committee for the last six years, I would like to discuss our effort, how the committee has evolved, and our support for the goals and potential benefits stated above.

NASS is a multispecialty society, and so is our Guidelines Committee, which includes MDs, DOs, physiatrists, orthopaedic surgeons, neurosurgeons, anesthesiologists, rheumatologists, psychologists, family physicians, and pain management specialists—all of whom provide care for spine problems. If you see spine patients, you might feel reasonably represented. The guidelines we develop should seem valid for your consideration, remembering that they are not protocols or algorithms that can’t be individualized. All committee members are volunteers; they soon experience the volume of information and articles to be digested, and the many hours spent in the effort.

Before members begin serving on the committee, they have to complete the University of Alberta’s online training program geared toward evidence analysis, to be able to systematically evaluate literature from an evidence-based perspective. The course takes 20-30 hours to complete. One quickly learns that an interesting journal article may not have enough valid evidence to be appropriate for a guideline. Conflicts of interest are also disclosed and may exclude one from the committee.

So, how does a guideline come into being? What is the methodology?

Step 1. The clinical question that deserves investigation needs be identified. The committee members submit specific questions on a chosen topic, such as spinal stenosis, and the questions are ranked for clarity and pertinence, to serve as the focus of the guideline. It is common to have 5-10 specific questions that need an answer. The guideline will answer only these questions, nothing more.

Step 2. Multidisciplinary “work groups” are identified from the committee members. Each group is assigned several questions to investigate and attempt to answer. 

Step 3. With the assistance of a medical or research librarian, the group comprehensively searches the medical literature, using specific search terms and parameters. The group then reviews the abstracts for relevance to the questions. The number of articles examined by each group can exceed 100, depending on their relevance.

Step 4. Each member of the group then reads and analyzes the full text of the articles and develops his or her own evidentiary table identifying the article’s “level of evidence” (see Table 1). Because multiple reviewers assign their own interpretation of the level of evidence, internal bias is lessened. When the findings are collated and further discussed in multiple conference calls, a consensus can be established as to whether the original question can be answered, and with what strength of evidence.

Step 5. Only after steps 1-4 are completed can an evidence-based recommendation be offered, and then only on the specific question that the work group has been assigned (see Table 2).

Step 6. The complete list of specific questions (some with answers, some without) is compiled, and the completed “draft guideline” is submitted to the whole committee for feedback and integration from the individual work groups.

Step 7. Submission for NASS board approval follows. Comments and suggestions are considered, but only when substantiated by a preponderance of appropriate evidence. Case in point: a recent criticism from an NASS board member was rejected by the Guidelines Committee, as without sufficient evidence for modification, affirming (at least in my opinion) the independence and integrity of our committee’s effort.

Step 8. Publication by the National Guideline Clearinghouse and appropriate general and specialty medical journals. 

By now, most medical journals list both an article’s level of evidence and the author’s disclosure of conflicts of interest. While these statements assist us substantially, what is different about our effort is that we investigate not just the stated level of evidence but also “What is the level of that evidence appropriate to answering the question specific to the guideline we are developing?” 

Reading an article for a guideline is substantially different than reading it for self-improvement. Is the data relevant to the guideline’s question? Did the patients in the article have the specific disorder or condition in question? Did the patients have the specific treatment? Was a “subgroup analysis” done to clarify that the results of the specific treatment apply to the specific disorder? Was there fallout? Was there “crossover” to another group? Was the study prospective or retrospective? Was it randomized or not, blinded or non-blinded? All these factors are important in determining the strength of the evidence.

Recently, in our updated review of “the natural history of untreated spinal stenosis,” after reviewing at least 60 articles specific to the question of the “natural” (untreated) history of this condition, we could identify not one that met all the criteria. Every patient had at least some treatment, ranging from anti-inflammatories to chiropractic. If anyone is aware of a truly untreated cohort of spinal stenosis, please let me know. I assure you, after investigating the Cochrane, MeSH, pubmed, and other databases, we could find none. Our guideline for spinal stenosis, when complete and updated, will reflect this finding.

Ultimately, it is not just the guideline, but also the recommendations from that guideline that have value to patients and practitioners. This is the place where physicians fear governmental and payor intrusion into their clinical practice. The language of the recommendation is important.

If a guideline recommendation is suggested, it has only moderate strength and is not authoritative. It’s not based on Level I evidence, but rather Level II or III.

To recommend a treatment one needs high quality data and strong Level I evidence, and usually multiple Level I studies that come to the same conclusion.

The term considered is used when the evidence is only Level IV or V.

Evidence-based research should lead to the evidence-based practice of medicine, should not intimidate the practitioner, and should have benefits to physician and patient alike. We must nevertheless guard against misuse of this information by administrative agencies that do not appreciate the intent of these voluntary efforts to improve care. Our guidelines respect the individual needs of physicians and patients. The guides cannot control care, but they can act as a resource for accessing valid research and medical information. The physician-patient relationship remains sacred.

The committee that I’ve served on for the last six years has matured from “opinion” to “evidence.” It remains a voluntary group, with no financial reward, and it consumes a lot of time, effort, and weekends. The satisfaction is in working through the many unanswered questions that I have always had in my clinical practice, and in working with a multi-specialty group of physicians who bring a broader perspective to these same issues.

Participating in guideline development is time-consuming but intellectually satisfying. Over 50 NASS members are currently involved in these efforts, with 19 of us currently working on the updated spinal stenosis guideline mentioned above. We consider this important in controlling the bureaucratic bear that threatens our profession, trying to force a box over our practice of medicine.