By Windy Cole, DPM, CWSP
“Science is curiosity, testing, and experimenting.”
Wound healing as a clinical specialty has evolved over the past 2 decades. The importance of wound care research in this emerging area of medicine cannot be overstated. Wound care research must continue to be conducted to facilitate the development of effective treatment protocols for patients suffering the numerous sequelae associated with chronic wounds. Wound management remains an area of medicine where advance practitioners play a key role in providing care and making decisions. It is therefore reasonable to believe that wound care clinicians of all backgrounds should also be active participants in wound care research. This article will detail the initial steps in developing a research proposal including determining a hypothesis and selecting the design of the study.
Designing and executing experimental studies requires attention to detail. The process starts with a good research question. The best research questions are those that are simplistic and focused. How do you come up with a good research question? Often research questions arise from a specific clinical problem or unusual patient case. Sometimes questions arise due to an interest in a new product or technique that might add benefit to patient care. All that is needed to begin is curiosity.
Once you have decided on your hypothesis the next step is to determine your study design. In this relatively young clinical specialty, there are a number of patient care needs that require investigation. Various research designs can be considered. Common types of trial designs include case studies, surveys, non-comparative studies, and randomized controlled trials (RCT). When considering the type of trial you would like to perform, it is important to consider the number of potential subjects available to participate and the potential implication of the study. A thorough literature search should also be conducted prior to determining the study design so that you may familiarize yourself with any previous research conducted on the subject matter.
Case Studies: Case studies are a great way to evaluate new dressings or devices. This type of trial can help determine the product efficacy in a certain patient population or wound type. Collecting data on patient satisfaction, unexpected side effects, and overall ease of use are examples of information that can be collected by means of case studies. While case studies are a good first step, often these trials do not provide enough evidence to make definitive conclusions based solely on the study outcomes.
Surveys: Surveys can be a helpful tool to measure the relationship between clinical intervention and patient behavior, tolerance, or outcomes. Surveys are often part of a larger trial design and can be used to determine product usability or to measure changes in patient quality of life. Information collected from survey data often influences the planning and design of additional studies.
Non-comparative Studies: Non-comparative studies follow a small cohort of patients receiving a specific intervention for a predetermined series of weeks. There is no control group in these types of studies. Often the focus of non-comparative studies is on new treatments or new indications for established therapies. In the process of developing novel treatments, it is common to perform a series of studies to obtain more information about the proposed new therapy. These studies are performed as a pilot to study a particular hypothesis prior to initiating a larger randomized controlled trial.
Randomized Controlled Trials (RCTs): Widely accepted as the ‘gold standard’ of clinical research, RCTs are a powerful tool to evaluate new wound care treatments or methods. RCTs provide what is commonly referred to as Level 2 evidence. Level 1 evidence is achieved only after multiple RCTs are performed on a particular intervention. RCTs test a large number of patients to determine the effects of a therapy and compare the results to a group of subjects not receiving the treatment (control). Subjects are randomly assigned into either group thus decreasing study bias. Because of their empirical rigor, RCTs are the study design of choice and widely accepted throughout the scientific community.
Start With a Poster Abstract
Participation in wound care research allows clinicians to contribute to robust and meaningful evidence-based treatment algorithms that will drive patient outcomes. I encourage all providers interested in becoming more involved in research to start by submitting a poster abstract for an upcoming scientific symposium. Abstracts are typically due several months (see box) before a meeting to allow time for peer review, so be sure to plan accordingly. Submitting a poster abstract is a great way to get involved with research. Here are some simple tips to keep in mind when preparing your abstracts.
Guidelines for writing an abstract
- Introduce the topic—what is the focus of the poster?
- State the problem—what is the question being addressed?
- Summarize why the problem exists—briefly summarize a review of the literature. Describe any shortcomings in previous research on this topic.
- Explain how the research question was answered—what experiments or testing was done? What parameters were measured and by what means? How was data collected?
- What were the findings—how was data compiled and analyzed? State the statistical method if applicable.
- What is the impact of the research—why should others care? How can this information influence clinical procedures or algorithms of care?
Windy Cole, DPM. CWSP, is an adjunct professor and Director of Wound Care Research at Kent State University College of Podiatric Medicine. Dr Cole also serves as the National Director of Professional Development and Clinical Education for Woundtech. She is board certified by the American Board of Foot and Ankle Surgery and the American Board of Wound Management. She has been a dedicated wound care advocate for two decades with interests focused on medical education, diabetic foot care, wound care, limb salvage, and clinical research. Her passion to help others has led her to participate in humanitarian efforts around the world. Dr. Cole has published numerous peer-reviewed and industry articles on these topics and is a sought-after speaker both nationally and internationally. She is an Editorial Board member of Wound Management and Prevention, Podiatry Today, The Foot Journal, and Lower Extremity Review. She is also the Podiatry Section Editor for the ePlasty Journal. She is a wound care advocate on the forefront of wound research and was the 2020 World Union of Wound Healing Silver Medal Award recipient for her work in Technology-driven Research. She sits on the advisory board of multiple emerging biotech companies and has been integral in collaborating on innovative research protocols in the space.