Evidence, research, and clinical practice: a patient-centered framework for progress in wound care.

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 (RCT), 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 three 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 process- es 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.