7 Things to Ask When Evaluating the Clinical Research Behind Pressure Care Products
“With so many choices of pressure care products on the market today, it can be challenging to find the right solution. When starting your search, ask potential suppliers to provide any research they have conducted on their products, then review it carefully and ask questions. At the end of the day, it’s about your patients, their health, comfort, and quality of life.”
According to the United Nations, the fastest growing age group in virtually every country in the world is persons aged 65 or over. By 2050, one in six people in the world will be over age 65, up from one in 11 in 2019. The number of those aged 80 years or over is projected to triple, from 143 million in 2019 to 426 million in 2050.
We in the healthcare and pressure care industries should take notice of these statistics. While this represents a tremendous business opportunity, the clinical effectiveness of pressure care products will become even more critical. Why? The aged consume the majority of healthcare services, an expensive proposition when resources are limited. Thus, not only should pressure care products support better outcomes; they should also be effective at avoiding and/or minimising the cost of care.
Quite literally, the pressure’s on to develop products that meet both objectives. Makers of pressure care products, including Caremed, offer research proving the clinical effectiveness of our products.
Just like everything else in the world, all research is not created—or conducted—equally. Research methodologies and even the equipment used to measure a patient’s condition are not infallible. While research findings are an important indicator of product effectiveness, prospective buyers must do a thoughtful review of a company’s findings, ask questions, and weigh the information before committing to purchase.
To help you navigate the review process, Caremed has put together a list of seven things to consider when evaluating the research behind pressure care products.
1) Does the supplier have clinical effectiveness research on their pressure care products?
This may seem like a simple yes or no, but surprisingly, it’s not. Clinical effectiveness research is more involved, with clearly stated objectives and methodology, and can be conducted internally or by an third party such an independent contract research firm. Some suppliers will offer pressure-mapping graphics as research, but that can be misleading. Such graphics are merely a “snap shot” and do not reflect a specific cycle of time or well-defined methodology. When presented with clinical effectiveness research, make sure it includes specifics on the objectives, methodology, results, and conclusion.
When looking at pressure maps it is helpful to get data on a full alternating cycle rather than a selected snap shot within that time period, this allows a clearer perspective on peak pressures and system performance.
2) Who conducted the research?
This is important, as you need to know the source of information. Some suppliers only do internal testing. Others do third party testing. And there are likely a few that do little or no testing at all. At Caremed, we cover all bases when developing new products, conducting both internal testing and third party independent clinical trials. An example of this is our new UTS™ (Universal Therapy System) pump-in-mattress system. Caremed first proved the system through internal tests and then went outside for a third party independent clinical trial to test the product’s effectiveness in real world care scenarios such rehabilitation centres and nursing homes. I’m pleased to report that the independent clinical data on our UTS™ system validated our internal findings on the system’s clinical effectiveness and also provided valuable feedback from case managers and mattress users.
3) What type of information was gathered?
Obviously, companies want data that presents their products in the best light. Ask for details what information was gathered in their product research. Clinical effectiveness research studies are designed to collect very specific data and therefore have specific objectives. Studies are typically designed to collect quantitative data, but qualitative data may also be included.
Here’s an example. The primary objective of a recent Caremed supported study was quantitative: to assess the incidence of pressure ulcers in 83 patients who spend 15-20 hours per day on our alternating-pressure mattress overlay over a 35-day period. None of the participating patients had existing pressure ulcers, but were at high-risk of developing them. The study had qualitative secondary objectives. We wanted to capture patient feedback on the comfort of the mattress, care staff feedback on operating the product and feedback on cleaning and maintenance. This information is very useful when comparing the effectiveness of different pressure care products.
4) What was the research methodology?
It’s important to know how the research was conducted. Caremed uses the latest technologies to measure the effectiveness of our products in pressure ulcer wound healing. For example, when our products are in a clinical trial, ultrasound is used to scan the wounds at the outset of the study to observe the tissue damage underneath the skin. Then after a set time, the researchers perform more ultrasounds to re-measure the wound. This illustrates not only the healing on the surface of the skin, but also shows the healing of damaged tissue underneath the skin not visible to the eye. This method of testing is performed in real life challenging care scenarios where the effectiveness is clear-cut and the evidence more quantifiable.
5) Where was the research conducted?
There is a significant difference between testing a product in a controlled environment and an actual healthcare environment. Ask your potential supplier where their pressure care products were tested and what the research parameters were. The environments of an internal corporate test lab, a hospital, rehabilitation centre, and private homes differ greatly. And you need to know this bit of information.
Recognising the importance of testing our pressure care products in real world situations, Caremed works in conjunction with independent tissue viability professionals to get our products in test out in the field in a variety of healthcare and in-home settings. This allows us to really put our products to the test, see how they perform with actual patients and caregivers, and capture meaningful data, insights and sometimes-unexpected observations. Again, information we all need to know.
6) What was the size and duration of the research study?
I’m going to bring up the pressure map graphic again. Does it represent a single patient or a defined patient population? Is it representative of a moment in time or a pre-determined period of time? Again, both are important to objectively establishing clinical effectiveness. Caremed’s recent third party independent research study involved a sample size of 90 patients at three rehabilitation centres and two hospitals who were tested using our pressure-care product over a 30-day period. The entire study took 15 months to complete. Extended studies involving large numbers of participants are costly to do, but the information gathered is more indicative of the clinical effectiveness of the product being tested than a less intensive study.
7) Is the supplier willing to conduct a research study with you?
While it may not be important to you to trial a pressure care product you’re considering in your facility, some healthcare organisations want the option of testing new products in their centres, with their staff and their patients. The advantage is seeing the product in action and having the opportunity to capture feedback from nursing staff, care managers, and even housekeeping/maintenance staff. Frontline employees can provide insights only available to those who have hands-on experience with the product being evaluated.
Caremed welcomes the opportunity to carry out and also support commercial partners with on-site end-customer trials and has supported large-scale clinical product trials in hospitals. We recently assisted a French partner that put more than 80 Caremed systems in trial with a leading hospital with excellent results.
With so much at stake, customers today should request to see a potential supplier’s research to gain a better understanding of the scope, methodology, and outcomes that support a product’s clinical effectiveness. An informed buyer will make better choices and realise better patient outcomes as a result.
If you have any questions or comments about pressure care products, the importance of clinical effectiveness research or on Caremed, please contact us. We’d like to hear from you.