Kara Couch, MS, CRNP, CWS, Family Nurse Practitioner and Certified Wound Specialist at the Wound Healing and Limb Preservation Center, George Washington University HospitalWe are gaining an ever-improved understanding of the cellular function of wounds and in wound healing. The science has advanced so much in the past few decades and the technology is aiming to keep up. Real world evidence and the acceptance of more patient-centered outcomes can be huge drivers of innovations that can improve healing, and enhance patients’ lives as they undergo wound treatment.
Randomized clinical trials have been challenging in the wound space. Wound patients vary tremendously – some are diabetic, some obese, some both. Some are old, some young, Most have underlying diseases of various severity. All of these scenarios can result in chronic nonhealing wounds. Yet in clinical trials, this variability is tightly controlled. In trials, for example, only diabetics within a certain age range, weight limit and type of wound may be included.. Then the results of the study really only apply to the narrow population. Practitioners look at studies for information, but clinical trials often don’t reflect the real world population in wound care waiting room.
Real World Evidence Will Open DoorsReal world evidence will open up the doors for wound care comparative evaluations and evidence gathered from real-life, real-patients, real-practice settings. This can help speed the space of innovation. So can study endpoints that reflect not only clinical healing, but quality of life improvements for patients.
We are making progress on those fronts. The FDA has opened the door for submission of real-world evidence. For the regulatory agency, it used to be only viable endpoint for wound healing studies was ‘time to complete closure.’ But we in clinical practice understand that there are many other measures and endpoints to consider. Just as cancer clinical trials have evolved from “time to cure” endpoints to consider days in remission endpoints, survival endpoints and side effects. The wound care space also needs trials with more realistic endpoints, and importantly, endpoints that reflect the patient experience.
For example, we can show benefits with clinical endpoints such as reduction of exudate levels and elimination of bio-burden. For patients, we can show reduction of pain, improvements in mobility, etc. Patient centered outcomes and patient-reported results can really shed light on treatment benefits. Today, we must use the same endpoints that the FDA set in 2006, but we don’t practice wound care the same way we did then. And patients certainly don’t have the same expectations they did back then.
Capturing Quality of LifePatient centered outcomes can help show that patients are experiencing a higher quality of life during their wound care treatment. Venous ulcer patients, for example, commonly lose multiple days from work or worse, have to file for disability –people with venous ulcers simply can’t stand on their feet for 8 hour work shifts. There are opportunities to show quality of life benefits in this space, like:
- Can we show that patients can remain productive and active in their lives and in the workforce?
- Can we demonstrate that, with particular treatments, patients are up, ambulatory and moving?
- Are there measures that can reflect patient lifestyle and quality of life?
Innovative wound technologies are more and more patient focused. Negative pressure wound therapy systems are now mobile and portable, enabling patents to carry on in their daily lives while still receiving best-practice treatments that in the past could only be delivered in a clinic setting. Wound dressings have improved. We can now combine multiple wound healing properties into a single dressing – so one bandage can address the many needs of a nonhealing wound. Dressings can do more than one function, but in a single application. This makes a huge difference for patients as well as to the providers responsible for time-consuming and painful-for-patients dressing changes.
Transformations in health care deliveryOverall, patients are really going to benefit from innovations and transformations in health care delivery systems. New focuses on population health and care coordination will benefit wound care delivery as systems and records better integrate.
Wound care patients, who tend to have a number of co-morbidities, often require many different medical specialists. A “venous ulcer” patient, for example, may need a vascular surgeon, a physical therapist, a nutritionist and any other number of specialist interventions. Health systems are improving methods to better coordinate across care providers and care settings. The emergence of designated wound clinics is also an asset to patients. Not only can these centers of excellence ensure best practices in care, but aligning wound clinicians in one space enables wound patients – who often suffer from mobility issues as a result of their wounds – to receive care in a central setting from a range of specialists.
As a care provider, I am excited about the innovations and new technologies and products that will serve my patients. As a researcher, I am excited about the promise of the data gathered from real world evidence to improve care. I hope that this can reduce some of the challenges and barriers we’ve confronted in the research space when it comes to wound care. And, I am hopeful that new endpoints in wound care research and a focus on patient centered inputs and outcomes will ensure that we are getting wound patients exactly what they need.
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