Editor`s Opinion: It’s All about the “E”

Perfection is the child of time. — Bishop Joseph Hall (1574–1656)

     Last April, thousands of wound care professionals attended the Spring 2009 Symposium on Advanced Wound Care. While most of the country focused on the economy and swine flu epidemic, the buzzwords in Texas were efficacy, effectiveness, and evidence. Although these terms have been clearly defined, their roles in wound care seem ambiguous.

     By definition, efficacy — the degree to which an intervention produces a beneficial result — can be determined only if you measure the effect of an intervention against something else, such as a control treatment.¹ Effectiveness addresses the fact that the intervention is beneficial when implemented under the usual conditions of care and can be ascertained by documenting outcomes of (usually large) groups of patients. Ambiguity and confusion abound about these two terms in wound care; it is not unusual to hear that one treatment is more beneficial than another by citing a series of case studies. Worse, even though the rationale for evidence-based care (as well as the definitions, criteria, and methods to develop this evidence) is well established and accepted in all areas of science and medicine,² suggestions that the discipline of wound care is somehow different and requires less rigor continue to be heard.

     First, it is important to note that while the gold standard for treatment evidence is the randomized, controlled, clinical study, healthcare is not just about providing treatment. For example, public health interventions, especially those outside the sphere of biomedicine, are generally tested using observational or quasi experimental studies.³ In wound care, a controlled clinical study design would not be the best method to provide evidence about aspects of care such as wound and patient assessment (including risk assessment).⁴ It is also true that some patient conditions, such as the presence of an open abdomen in persons with a stoma (as described in this issue of OWM⁵) are so rare, conducting a randomized controlled study to determine the most efficacious method to manage these patients is simply not practical. However, one should at least know that the open abdomen treatment itself is more effective than the standard of care.

     Sadly, in wound care, the extent to which one treatment modality is better than another is often unknown. Cases-in-point include data presented by Ahearn⁶ and Nease⁷, also in this issue of OWM, that suggest the most frequently used negative pressure treatment modality recommendations are less-than-optimal for wound healing to occur and may have evolved based on the capabilities of the technical equipment available at that time. Although evidence regarding its efficacy in a variety of common wounds remains sparse,^8-10 this treatment has been provided to more than 3 million wound patients. 6 Hopefully, one day we will be able to look back and conclude that all of these patients received good care and had excellent outcomes. Unfortunately, as we know from other areas of medicine, this is not always the case. After observational studies suggested that hormone replacement therapy (HRT) taken by postmenopausal women had a protective role in cardiovascular disease (CVD), millions of healthcare professionals started prescribing it. A number of years later, when results of the controlled clinical studies became available, it was learned that HRT had the exact opposite effect. Once efficacy results became known, not everyone stopped taking HRT because for some the benefits were greater than the risk of CVD, but everyone was now able to make an informed decision.

     Similarly, it has been argued that healing efficacy is just one variable and that outcomes such as patient comfort can guide the treatment decision process. Although this is certainly true, that argument does not negate the need for safety and efficacy data. Both are required to inform decisions about potential treatment benefits and risks. As described in the US Food and Drug Administration’s¹ guidance document for the development of wound treatments, “Products intended for wound management may provide important patient benefit without improving the incidence or timing of wound closure relative to standard care. However, it is important to demonstrate that such products do not significantly impede healing.”

     Evidence-based treatment is here to stay because patients deserve nothing less. Evidence must include treatment efficacy (it is at least as good as or better than….) and effectiveness (it works for them). Science and time have taught us it cannot be either/or and that, in the absence of efficacy, effectiveness may exist only in the eyes of the beholder.

This article was not subject to the Ostomy Wound Management peer-review process.

1. United States Food and Drug Administration, Center for Devices and Radiological Health. Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds — Developing Products for Treatment. June 2006. Available at: www.fda.gov/cder/guidance/5512fnl.pdf. Accessed: May 1, 2009

2. Bolton L. Evidence-based medicine in wound care: in support of the renaissance. Ostomy Wound Manage. 2008:54(6):6–8.

3. Baretto ML. Efficacy, effectiveness, and the evaluation of public health interventions. J Epidemiol Community Health. 2005;59:345–346.

4. van Rijswijk L, Braden BJ. Pressure ulcer patient and wound assessment: an AHCPR clinical practice guideline update. Ostomy Wound Manage. 1999;45(suppl 1A):56S–67S.

5. Steenvoorde P, Outerl A, Neijenhuis P. Stomal mucocutaneous dehiscence as a complication of topical negative pressure used to treat an open abdomen: a case series. Ostomy Wound Manage. 2009;55(6):44–48.

6. Ahearn C. Intermittent negative pressure wound therapy and lower negative pressures — exploring the disparity between science and current practice: a review of the literature. Ostomy Wound Manage. 2009;55(6):22–28.

7. Nease C. Using low pressure, negative pressure wound therapy for wound preparation and the management of split-thickness skin grafts in three patients with complex wounds. Ostomy Wound Manage. 2009;55(6):32–42.

8. Wasiak J, Cleland H. Topical negative pressure (TNP) for partial-thickness burns. Cochrane Database of Systematic Reviews 2007, Issue 3. Art. No.: CD006215. DOI: 10.1002/14651858.CD006215.pub2.

9. Gray M, Peirce B. Is negative pressure wound therapy effective for the management of chronic wounds? J WOCN. 2004;31(3):101–107.

10. Ubbink DT, Westerbos SJ, Nelson EA, Vermeulen H. A systematic review of topical negative pressure therapy for acute and chronic wounds. Br J Surg. 2008;95:685–692.