Skip to main content

Advertisement

ADVERTISEMENT

Editorial

Editor`s Opinion: Deja Vu

  You know you have been practicing in the area of wound, skin, incontinence, or ostomy care for some time when you can predict that every review of the literature will contain at least one sentence that reads something like this: "At this time, there is not enough evidence to ...."

If you have been reading or writing many evidence-based reviews, you probably can even predict where the sentence, "controlled clinical studies are needed," will appear.

  While controlled clinical studies are neither appropriate nor necessary to test all hypotheses and interventions, they are, for better or for worse, the gold standard for determining treatment safety and effectiveness. Unfortunately, controlled clinical studies also are a rare species in this area of medicine. Worse yet, existing studies are often fraught with design flaws, despite considerable advances in the science of conducting clinical studies, assessing wounds, understanding risk factors, and performing statistical analysis to control for variables that cannot be controlled. In their on-going search for evidence to support clinical treatment decisions, many of the Cochrane Wounds Group treatment reviews end with conclusions such as "evidence of beneficial or harmful effect cannot be ruled out because the number of studies is small, have methodological limitations, and a small number of participants."1

  Attempts to draw conclusions about different treatments by grouping existing data and conducting a meta-analysis similarly tend to fall short of their goal because many studies are not reported using standard clinical study reporting guidelines. For example, after retrieving 93 controlled and noncontrolled leg ulcer study publications for possible inclusion in a meta-analysis model, researchers found that 58 could not be used because crucial information such as patient demographic information by treatment modality was missing.2 In fact, only three pressure ulcer and three venous ulcer treatment protocols of care had sufficient information (> 100 wounds) to be included in the analysis.2 Compare this to the dozens and dozens of products available to manage these wounds and you begin to get the picture.

  Life isn't much better in the land of prevention. As Figliola reminds us, we do not even have clinically valid standards and definitions for one of the most commonly used types of support surfaces.3 To that end, the National Pressure Ulcer Advisory Panel and participating clinicians and manufacturers deserve our praise for taking the initiative to develop uniform terminology, test methods, and report standards for support surfaces.4 Such standards will go a long way toward helping clinicians make informed support surface decisions and will hopefully result in performance, not feature-based, support surface categories. But we should not wait for their release to provide evidence about their comparative safety and effectiveness. Only the results of prospective, controlled studies can provide those answers.

  So why have we been reading the same "there is not enough evidence..." sentences year after year after year? When you have been around for a while and asked manufacturers for clinical data to substantiate product safety and effectiveness, you have probably heard all the excuses I have heard during the past 20 years or so: "Too complex." "Too expensive." "These are just devices." "Clinicians are not really interested...."

  First, truth be told, simple clinical studies do not exist in any area of medicine. However, during the past two decades, we have learned a great deal about variables that may affect study outcomes and how to control for those variables by using the right study design and statistical analysis methods. Second, clinical studies are expensive - but so are the glossy advertisements, case studies, and testimonials that end up in our recycling bins. Third, what are referred to as "just devices" are used to prevent serious complications, treat debilitating conditions, and help people manage the consequences of surgery, illness, or birth defects. If you are on the receiving end of "just devices," wouldn't you want to know that the proposed treatment is safe and effective? Studies are needed because most of these devices are exempt from pre-market FDA notification, and some are even exempt from adhering to Good Manufacturing Practice regulations.5,6

  Last, but not least, when every review contains sentences about the lack of available data, someone must be interested. Indeed, that "someone" is every clinician who has a license to practice and a promise to keep - that is, to provide the best care possible. How can we provide the best care possible when we ask for clinical studies and receive "evidence" of "positive results" in 10 or 20 patients?

  The time of trial-and-error has passed. We cannot afford to "just try" something. Patients cannot afford to be the recipients of unproven treatment strategies without consenting to be part of a study. Unless a treatment modality is safe and effective, it cannot be cost-effective, and unless it is cost-effective, we can no longer afford it.

  We are at the beginning of a new year. Let's hope it will not be deja vu.

1. Cochrane Group. Cochrane Wounds Group Reviews. Available at: http:www/cochranewounds.org. Accessed: December 4, 2002.

2. Kerstein MD, Gemmen E, van Rijswijk L, Lyder CH, et al. Cost and cost effectiveness of venous and pressure ulcer protocols of care. Dis Manage Health Outcomes. 2001;9(11):651-663.

3. Figliola RS. A proposed method for quantifying low-air-loss mattress performance by moisture transport. Ostomy/Wound Management. 2003;49(1):32-42.

4. National Pressure Ulcer Advisory Panel. The Support Surface Standards Initiative. Available at: http://www.npuap.org/s3i.htm. Accessed December 6, 2002.

5. van Rijswijk, L. Product safety and business interests: A delicate balance. Ostomy/Wound Management. 1999;45(3):4-5.

6. United States Food and Drug Administration; Device regulations. Available at: http://www.accessdata.fda.gov. Accessed November 12, 2002.

Advertisement

Advertisement

Advertisement