Throughput and the Diabetic Foot

Can Throughput Help Prevent Diabetic Foot Ulcers and Amputations?

The American Diabetes Association guidelines for management of diabetes include a series of general recommendations for foot care. (1) Their first recommendation is that the “feet should be inspected at every visit for patients with evidence of sensory loss or prior ulceration or amputation and comprehensive foot evaluation for others at least annually to identify risk factors for ulcers and amputations.”

The recommendation is clear, regardless of the patient’s level of risk, every patient with diabetes should have at least an annual comprehensive foot evaluation. The reality is that this recommendation is easier said than done. The recommendation does not stipulate who should perform the exam or what its contents should include. It is assumed the exam would be done by the patient’s primary care provider.

What Should a Comprehensive Diabetic Foot Exam Include?

A literature search revealed that the exam should start with a focused lower extremity patient history. It should document the patient’s social, surgical, neurological and vascular history. It should be complimented by neurological, vascular, dermatological and musculoskeletal physical examinations. People with diabetes, as well as a surprisingly high number of people with prediabetes, may develop systemic complications due to chronically elevated blood sugars. A common and critical complication /comorbidity of the feet is sensory neuropathy which is characterized by nerve damage. This condition can change or reduce the ability of a patient to sense pain, heat, and cold in the feet and may result in ulcers, infections and amputations. Peripheral vascular disease complicates the situation as a wound is deprived of vital oxygen and nutrients necessary for wound healing. (2)

What are the Impediments to Throughput for Evaluation and Management of the Diabetic Foot?

Primary Care Providers

A medical provider’s ability to increase their patient Throughput effectively and efficiently will reduce the number of DFU’s, infections and amputations. This is because a greater number of patients can be evaluated and each patient’s unique risk factors for developing a foot ulcer can be identified and appropriate preventive proactive care can be instituted to prevent the ulcer, infection and amputation.

However, there is substantial research documenting the issues of primary care providers and diabetes. Primary care physicians treat at least 90% of the 34.2 million patients in the United States with diabetes and most people with diabetes worldwide. They are considered the “gatekeepers” for referrals to specialists. (3)

When it comes to primary care physicians evaluating and managing the diabetic foot, unfortunately many patients with diabetes never receive a foot exam, not even a quick look at their feet. The reasons for this vary and usually include: not enough time to do the exam, not enough training to do the exam, not enough interest to do the exam. All too often when a foot ulcer is identified the treatment is application of a topical antibiotic like Neosporin and to “watch it.” A woefully inappropriate response to what could be a life-threatening medical problem.

The conclusion of a 2017 article in the BMJ Open Diabetes Research & Care shows a disconnect between PCP's’ perceptions of adherence to screening guidelines and actual practice, and highlights limited referrals to Diabetes Prevention Program/Diabetes Self-Management Education programs. (4)

A study conducted by researchers from Johns Hopkins University showed about 25 percent of physicians misdiagnosed people with diabetes as having prediabetes. In addition, the average doctor didn't know 33 percent of the risk factors for prediabetes, are unfamiliar with prevention or management of the condition, and overall underscreen for it. “There are implications for changing national guidelines and policies regarding type 2 diabetes prevention, including establishing measures of quality for diagnosing and managing prediabetes," (5)

In a 2019 another study conducted by researchers from Johns Hopkins University surveyed over 1,000 primary care physicians to determine how well they can help patients avoid diabetes. The researchers found that many of the doctors who responded to the survey aren’t up-to-date on the latest diabetes risk factors or prevention measures. The results also suggest that 25 percent of PCP's may be identifying people as having prediabetes when they actually have diabetes, which could lead to delays in getting those patients proper diabetes care and management. (6)

Patients with Prediabetes are Also Affected

It’s obvious that it’s not just people with diabetes who are affected by this “knowledge gap.” There is disheartening news for the nearly 88 million Americans and the nearly 500M people worldwide affected with prediabetes, too. The real concern for the foot health of patients with prediabetes is that the prevalence of diabetic peripheral sensory neuropathy was higher in those with prediabetes than those with normal glucose tolerance and to that in participants with recently diagnosed diabetes. The results were similar in a recently published study that showed that health care providers may lack the knowledge to diagnose and even treat prediabetes. (7) If providers have difficulty diagnosing diabetes and prediabetes, how can they be expected to appropriately evaluate and manage the comorbidities of the conditions?

Not Enough PCP’s to Go Around

According to new data published in July, 2020 by the Association of American Medical Colleges (AAMC), the U.S. could see an estimated shortage of between 21,400 and 55,200 primary care physicians by 2033. Those figures are part of the overall data predictions by the study of a shortfall between 54,100 and 139,000 of all physicians (primary and specialty). This will only complicate access for patients to receive the recommended yearly comprehensive diabetic foot exam from PCP’s. (8)

Is it any wonder that patients with diabetes or pre diabetes fail to get a legitimate yearly comprehensive diabetic foot exam from their Primary Care Providers? There must be a better way to facilitate the evaluation and management process of the comorbidities of diabetes. Throughput may be part of the solution.

Throughput and the Diabetic Foot

For patients with diabetes we can define the issue of throughput as an inability to be properly evaluated and managed in a timely fashion to prevent the onset of complications caused by the comorbidities of the condition: foot ulcers, amputations, retinopathy, cardiovascular dysfunction and renal disease. The objective of throughput as it relates to the diabetic foot is to minimize the amount of time needed for a patient to be evaluated and facilitate treatments for any pathology noted.

The Best of All Possible Worlds

In a “best of all possible worlds” scenario the following would represent the steps appropriate for Throughput to be use as a successful strategy for preventing diabetic foot ulcers, infections and amputations.

Standardization of Care

There is currently no standardization of care despite published guidelines. Providers either use templates they find on the web, or a “do it yourself” method (what they know from reading journals, etc.) or fail entirely to provide any serious care. The issue of lack of addressing and using “best practices” for patient care may be addressed by a standardized, evidence based, universally accepted comprehensive foot exam.

Screening and Risk Stratification

Patients should be screened and stratified into risk groups such as those developed by the International Working Group on the Diabetic Foot. By using criteria agreed upon by international foot health specialists the severity of a patient’s comorbidity related to their diabetes may be defined by the number and type of risk factors that can be identified, evaluated and documented in the presence of, or in advance of the development of foot pathology.

Evaluation and Management

Using internationally accepted standardized screening and risk stratification methods, current foot pathology can be identified and appropriate care can be started promptly. For example, in the event that a foot ulcer is identified, care can be instituted promptly with evidence based medical treatments to prevent the ulcer from becoming infected, thus preventing the need for hospitalization and possible amputation. Further, by understanding each patient’s unique risk factors for developing a foot ulcer, appropriate preventive actions can be taken to prevent re-ulceration.

Use of Qualified Adjunct Medical Personnel

The issue of adequate numbers of current providers who could receive patients with diabetes combined with the predictions of future dwindling number of providers is troubling. Another variable complicating the number of provider issues affecting Throughput is time constraints, which limit foot exams for patients with diabetes. Limited time constraints cause “competition” for a myriad of medical problems PCP’s are responsible for treating. The solution to the issue of decreasing number of providers and time constraints is to use qualified adjunct medical personnel, such as nurse practitioners, nurses or trained medical assistants to perform the tasks including the history and to administer the foot exam. This would be similar to performing an EKG exam. In this scenario the PCP does not perform the exam, however, evaluation for medical care and consults are based on the results of the exam. The decision-making process remains in the hands of the PCP. Developing care management processes that shift the responsibilities of higher-level providers to lower level providers can materially reduce patient length of wait and increase Throughput.

The Nuts and Bolts of the Exam

To facilitate Throughput of the annual comprehensive diabetic foot exam, it should be available via a computer-based program that would be available via the internet. The results of the exam should be automatically entered into the patient’s electronic medical record. There should be a dashboard displaying the history and exam results for the ease of review for the decision-making process of patient management by the PCP. Ultimately when enough data are collected, machine learning and artificial intelligence will be used to expand the evaluation and management parameters and provide insights into all of the comorbidities and how they interact with each other. This could not be done by any human medical provider.

Centers of Excellence

The last portion of my “best of all possible worlds” scenario for accelerating Throughput and preventing foot ulcers, infections and amputations is to establish Centers of Excellence. These facilities would be designed to focus on the task of evaluation and management of the comorbidities of diabetes, thus facilitating Throughput. In this scenario, using 15 minutes per each patient foot exam, each examiner could evaluate and document their findings for 25 patients every day, and using 250 working days in a year each examiner could then process 6,250 patient visits each year. Ten examiners could process 62,500 patient visits, many more than might be done at any PCP office. Centers of Excellence could be established in major population centers to facilitate Throughput. This scenario is not a dream. The concept was devised and placed into action by Graham Leese, MD, where he developed Centers of Excellence for diabetic retinal screening for the National Health Service of Scotland.

The Ultimate Benefit of Throughput for the Diabetic Foot

The ultimate benefit of throughput will be that the guideline of the American Diabetes Association will come closer to being met. The evaluation and management of the diabetic foot will change from being reactive to proactive. The number of “train wrecks” (people who present with ulcerated and infected feet) will decrease significantly as will the number of ulcers infections and amputations. This will engender a better quality of life for patients and reduce the cost of healthcare.

(1) https://care.diabetesjournals.org/content/40/Supplement_1/S88

(2) https://www.diabetesselfmanagement.com/managing-diabetes/complications-prevention/your-annual-comprehensive-foot-exam/

(3) Mayo Clin Proc. 2010 Dec; 85(12 Suppl): S3-S4.

(4) https://drc.bmj.com/content/5/1/e000406**

(5) https://www.upi.com/Health_News/2019/09/10/Many-primary-care-doctors-underscreen-misdiagnose-diabetes/1951568133331/

(6) https://www.diabetesincontrol.com/pcps-lack-knowledge-of-prediabetes-risk/

(7) Lee CC, Perkins BA, Kayaniyil S, Harris SB, Retnakaran R, Gerstein HC, Zinman B, Hanley AJ. Peripheral neuropathy and nerve dysfunction in individuals at high risk for type 2 diabetes: the PROMISE cohort. Diabetes Care. 2015;38:793–800. doi: 10.2337/dc14-2585. [PubMed] [CrossRef] [Google Scholar]

(8) https://www.pcpcc.org/2020/07/10/new-report-confirms-growing-shortage-primary-care-physicians