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Question: When is a standard of practice not a standard of practice? Answer: When it’s actually just a guideline that hasn’t been validated through clinical trials.
This distinction, which seems clear-cut and easily identifiable, has not stopped the interchangeable use of the terms "standard" and "guideline." Add to the list "critical pathways," "consensus statement," and "algorithm" and you have a recipe for widespread confusion among clinicians who treat wound patients.
The quandary stems from the fact that these terms are often used without regard for their true meaning, says Maryanne McGuckin, DrSc Ed, MT, senior research investigator at the University of Pennsylvania School of Medicine in Philadelphia. "Someone says they’re going to develop a clinical practice guideline, another says they’re developing a critical pathway. For some reason, people assume they’re the same thing, but they’re definitely not."
McGuckin finds that many wound care practitioners assume that the guidelines for treating pressure ulcers issued by the U.S. Department of Health and Human Services’ Agency for Health Care Policy and Research (AHCPR), is the standard of care. It’s not, and the distinction is important. (For details, see story on p. 5.)
Clinical practice guidelines are usually based on consensus and on prior research reported in the literature. They stipulate that, under given circumstances, treating a certain condition is best done in a certain way. But many practices have not been tested for validity or reliability, according to Lia van Rijswijk, RN, ET, a wound care consultant in Newtown, PA. "People constantly mix up the terms. We put protocols out there and hope they will work, but how well they work, we’ll have to wait and see, as a rule. One big mistake that people make is to think that the AHCPR pressure ulcer guideline is the law. It’s not. It has been very useful, but these are living documents that are always evolving."
Guidelines and standards lie at opposite ends of the care protocol spectrum. A guideline may be the foundation upon which a standard of care is eventually constructed, but only after the practices spelled out in that guideline are validated through prospective clinical trials.
"The progression is, ideally, to begin with a consensus statement, then proceed to an algorithm of care, then form a guideline, then form a standard," says McGuckin. A standard, she stresses, is not truly a standard until it has been validated in some type of controlled clinical trial. "If that hasn’t been done, then it’s still just a guideline."
The pressures of managed care to reduce the costs of all aspects of clinical practice has led, in many specialties, to the development of critical pathways (also referred to as clinical pathways) that specify the sequence of steps for patient care. Critical pathways are often developed from existing practice guidelines. They are goal- and outcome-focused and provide the sequence and timing of treatment thought to be ideal under a given set of clinical circumstances or assessments. Critical pathways contain a time frame for measuring patient progress.
"The purpose of critical pathways is to standardize those treatment sequences that provide the best, most cost-effective care. For wound patients, care has been so fragmented that there’s a lot of pressure by insurance companies to develop such plans," says McGuckin.
Developing a critical pathway is one way to meet that pressure, but because the parameters of chronic wound care are so fluid and because critical pathways are so focused, their application to chronic wound care is inappropriate, says van Rijswijk. "There is no critical pathway for chronic wound care that is really useful," she says. "Some have been developed, but they’re not validated or reliable. It’s commonly accepted that a certain percentage of surgical patients will be outliers on critical pathways. For chronic wounds, based on what we know now, you’d probably see more than 50% to the left or right side of the curve. That tells us that we don’t yet know enough about chronic wound care to create critical paths."
More appropriate for wound care are algorithms step-by-step guidelines for practitioners to follow under a given set of clinical assessments and circumstances. Whereas critical paths include time frames by which to gauge a patient’s progress, algorithms do not include this component. "Critical paths are much more detailed and time-sensitive," says van Rijswijk, adding that such inflexibility makes them of questionable value for chronic wound care at this time.
Algorithms, van Rijswijk explains, are far more flexible. Often, the care options through which they guide clinicians are based on visual cues. For example, the algorithm might ask if the wound is covered with necrotic tissue. If so, it provides appropriate options. Algorithms can be very general or highly detailed and include goals of care and expected outcomes.
Van Rijswijk, who served as a member of the University of Pennsylvania National Advisory Panel for the Venous Leg Ulcer Guideline, (see "Birth of a Practice Guideline," p. 6), also developed a set of wound care algorithms for ConvaTec, a division of Bristol-Meyers Squibb Co. in Princeton, NJ. The algorithms cover four subsets of wounds: dry wounds, moist wounds–lightly exuding, moist wounds–moderately exuding, and wet wounds. (See algorithm, inserted in this issue.)
Eventually, with adequate and plentiful research, van Rijswijk says she hopes critical pathways will be developed for wound care. "For leg ulcers, for instance, we may be able to develop a critical pathway based on reduction of ulcer size, but I’d be uncomfortable with people using that as a criteria now," she says. "My biggest fear is that people will pick up on a care protocol and say, This is a critical path for pressure ulcers,’ and the insurance companies will accept that and use it to determine reimbursement," she says.
"It’s too early to make these kinds of determinations, and it will be much more difficult to backtrack once we’ve latched onto something we’ve called a critical pathway. I don’t want some lawyer coming in and saying I’m taking this to court because you didn’t follow the critical path,’ when in fact there was no valid and reliable critical path to follow," van Rijswijk says.
Critical pathways, she adds, will be a realistic goal once more data have been systematically collected, but the effects of many patient and wound variables on outcome remain uncertain.