Evidence, Research, and Clinical Practice

Abstract

Traditional criteria used in selecting wound care interventions are being slowly replaced with an evidence-based practice approach. The value of such an approach for providing optimal care has been established, but the definition of evidence-based care and the process used to generate evidence continue to evolve. For example, the role of studies developed to demonstrate efficacy, randomized controlled trials, the value of effectiveness studies designed to evaluate outcomes in real world practice, and the use of disease-oriented (interim) study outcomes for wound care research, such as reduces wound fluid or improves granulation tissue formation, have been topics of international conversations and consensus documents. In addition, the use in some clinical studies and most systematic study reviews of ingredient or characteristic-based categories to group products that may not share a common operational definition of how they function has led to a high variability in outcomes, resulting in inconclusive or low-level evidence. These concerns and debates, along with their influence on practice, may cast doubt on the value of evidence-based practice guidelines for some clinicians, slowing their rate of implementation, and extending the discussion about definitions of evidence-based care and the relative merits of various research designs. At the same time, amid growing concerns about medical device safety, clinicians must answer 3 questions about an intervention and its related products or devices in order to provide safe and effective care: (1) Can it work? (2) Does it work? (3) Is it worth it? Reviewing current knowledge about wound care, wound treatment modalities, and the basic principles of research within the existing framework of questions to be answered suggests a clear path toward obtaining much-needed evidence. In wound care, using clearly defined processes to study patient-centered outcomes (eg, quality of life, complete healing) and only product groupings that meet an operational definition of functioning (eg, moisture-retentive) will help clinicians decide whether an intervention can work and does work and whether the value of the clinical and economic benefits is greater than the potential harm and cost.

Back to the Future in Wound Care

“…Because most of the products we use are so-called class I 510(k) exempt devices, no research or even premarketing regulatory notification is needed before they show up on our shelves. 2 Hence, for many products it is very difficult to ascertain whether a product can work, does work, and is worth using. The other big challenge is the dressing classification system we use.…”

“…For example, it would include examining and adopting definitions such as the operational definition of moist wound healing developed almost 2 decades ago. 2 It would require manufacturers to conduct tests to ascertain if the product does meet that definition for a lightly, moderately, or highly exuding wound (eg, laboratory tests to ascertain moisture vapor transmission rate in order to be considered a moisture-retentive dressing to manage the assessed level of wound exudate). Adopting a different paradigm and developing valid and reliable operational definitions is no small feat-but it can be done.…”

“…The innovation itself is generally not questioned. But in wound care, we continue to have previously detailed2 unique challenges. These unique challenges may help explain why we should take a good hard look how the innovations themselves, instead of the clinicians and the systems in which they practice, may have hindered implementation of evidence reported many decades ago.…”

“…Second, “modern” dressings cost more than gauze. In addition to potential reimbursement problems, the question “is it worth it?” cannot be answered for many products 2. Third, providing evidence-based basic wound care and changing dressings is not exactly a status-conferring activity.…”

“…cannot be answered for many products. 2 Third, providing evidence-based basic wound care and changing dressings is not exactly a status-conferring activity. The status-conferring element of adopting innovations (or not) is often underestimated but may help explain why it took almost 2 centuries for sailors to get citrus fruit and thousands became ill in the meantime while new ships and guns were readily deployed.…”