When it comes to pressure injuries, prevention is the holy grail. Any wound that can be stopped before it starts saves the patient plenty in pain and suffering and saves the facility money in treatment and staff time as well.
That's why long-term care professionals often seem so driven to improve prevention. They examine all the latest inventions with hope and longing, anxious to find a solution to the painful ulcers. They test new surfaces, new techniques, new ideas.
They read all the literature on advances that could help them cut occurrence rates down to a minimum... and then even less, with the next round of breakthroughs.
Finding solutions, however, is never a simple matter. Even when they have access to clinical trials that test the outcomes they need, interpreting the results and applying them to real life cases is more complex than it appears.
According to Prof. Jan Kottner, Director of the Clinical Research Center for Hair and Skin Science at the University of Berlin, the decision makers have to consider a variety of elements before implementing a workable solution.
First, they need to look at the latest research - the published papers with the results of the latest clinical trials. Next, they need to consider the clinical expertise at their own facilities as well as patient preferences. Finally, they need to consider policy frameworks, legislation, and reimbursement policies to gauge the practicality of a particular solution.
Narrowing Down the Methods of Prevention
Prof. Kottner explains that pressure injury prevention comes down to two critical steps:
1. Risk assessment - how likely the patient is to develop a pressure injury
2. Based on the risk assessment, most preventative measures fall into the following categories:
- early mobilization
- support surfaces
- preventative skin care
- microclimate control
The process of prevention continually moves between these two steps. For example, a question might arise about repositioning: does the two hour rule still apply? The answer is found in assessing the risk of the patients in question. That assessment may lead to a regime of repositioning that is more or less frequent than the general guideline.
The best and most reliable results, however, are from clinical trials, especially when they are directed at outcomes that address the specific needs of the patients.
The Stages of Clinical Trials
Clinical trials on outcomes to help prevent pressure injuries typically go through three stages.
The key to a successful study is finding the right outcome for testing. An outcome is a practical question that is being answered by the study. For example, an important outcome is finding out which support surface is more successful at preventing pressure injuries.
1. Input - determining which solution is better at achieving the desired outcome
For support surfaces, the input would be one support surface versus a different one.
Inputs vary greatly depending on the chosen outcomes. They can be patient characteristics, environment, behaviors, tradition, exposures, or treatments.
2. Processing - the data collection during the trial
This is the actual trial, putting the inputs to the test against one another.
Prof. Kottner calls this stage the "black box" because many factors come into play alongside the inputs. It is difficult to limit the results only to the inputs and the outcomes.
3. Response - what happens in the end
How did the two surfaces compare in the trials? How many patients developed pressure injuries using one surface and how many using the other one?
If the desired outcome is determining which support surface is better for pressure injury prevention, the three stage clinical trial would provide an answer through direct testing.
Challenges in Trial Assessment - and the Solutions
Even with clear results from the trials, the variables could still be hard to analyze. For example, in the example of the support surface, is the critical question about the number of pressure injuries or the number of people who develop them? What if a patient develops more than one? Is the trial about how many pressure injures develop or how many people develop them?
Other questions could be about whether it matters where the PI developed, or whether the past history of patients factor into the incidence rate? Is the study big enough, with enough subjects, to make its results are compatible with other studies?
To overcome the challenges, Prof. Kottner suggests using a COS (core outcome set), a standardized collection of outcomes measured and reported in all trials for a specific clinical area. That solves the questions about compatibility with other trials, and also provides a set of standards for analyzing the trial in question.
In the area of pressure injuries, a COS is already being developed under the name of OUTPUTs (The Outcomes for Pressure Ulcer Trials project) by the Cochrane Skin Group Core Outcome Set Initiative.
Prevention is the Key
Clinical trials can help health care professionals make informed decisions on pressure injury prevention. But the results they offer can be confusing if the process is not standardized. With the cooperation of other clinicians, they offer the greatest chance for learning exactly which products and behaviors to select for the best outcomes.
For the patient, it could make a world of difference.