What Do Medical Records Reveal About the Effectiveness of Care for Diabetic Foot Health?

Medical records are frequently the source of clinical data used in research of the diabetic foot. However, due to variations in the records, problems can result in collecting and using the data for such research.

Worldwide, there are vast differences in the type of medical record, the quality of the medical record and how providers and or health systems manage the data it contains. Medical records can range from simple, handwritten notes that often include some short cuts or abbreviations, to sophisticated electronic health records. The issues of who collects the data and how it is documented will ultimately influence how it can be harvested, manipulated, and used in research.

The content of the foot health data in the medical record can vary from provider to provider. This data difference in record keeping may have influence from the author’s education, training, and experience. For example, one might diagnose a deformity of the first metatarsal phalangeal joint as: osteoarthritis; exostosis or bone spur; hallux abducto valgus; hallux valgus; hallux rigidus; a hallux limitus; or a bunion. Which is correct? Several of these diagnoses may be correct or none of them may be correct, depending on the author and their perception of the pathology. Therein lies a problem. The medical record of a diabetic foot exam performed by a podiatrist may be significantly different from the one penned by a primary care physician. This is one conundrum that faces researchers, and one important reason why the use of medical records is so tricky for diabetic foot health research.

How Might a Scottish System Lead Us to Better Medical Records?

A dozen researchers across Scotland co-authored a study on foot ulcers and risk of amputations or death.¹ Their research revealed vital information from the patients’ medical records regarding current statistics on foot health and diabetes in addition to new information on previously unrecognized variables that can result in foot ulcers, amputation, and death.

The authors included nearly 233,000 patients with diabetes (23,000 type 1 and 210,000 type 2), and found through medical records that 13,000 had a previous foot ulcer, 9,000 developed a first foot ulcer, and nearly 49,000 died.¹ They also found that common factors that led to amputation or death included: age; male sex; smoking; hypertension; body mass index (BMI); systolic blood pressure; hemoglobin a1c; and cholesterol. Additionally, these medical records revealed that death and amputation was more common if a patient had existing vascular disease, end-stage renal disease, or established cardiovascular risk factors or events.¹

Overall, their multivariable analysis revealed that experiencing a foot ulcer was associated with a 2.09-fold and 1.65-fold increased risk of amputation or death for patients with type 1 and type 2 diabetes, respectively. Interestingly, the researchers also identified and recommended intervention for two new risk factors that could impact diabetic foot ulcers and death; social deprivation and mental illness.¹

The authors concluded that their study reinforced the association between foot ulcers and mortality and morbidity, and therefore this information is relevant towards measuring effectiveness of care for those with diabetes.

What Challenges Does the US Face In Creating a Similar Database?

How is it that these Scottish researchers were able to produce these thought-provoking and change-inspiring results in their research? The answer is in part due to the multiple sources of high-quality data used in the study.

In the US, many of us observe that patients often switch insurers and medical providers, resulting in a disjointed and unreliable series of medical records that are not appropriate for data mining and research. Scotland’s National Health Service (NHS) records and preserves each patient’s lifetime health journey in one national medical record from cradle to grave. Additionally, there is a special medical record dedicated to documenting information focused on patients with diabetes called Scottish Care Information-Diabetes (SCI Diabetes). This database is a disease-specific electronic patient record covering more than 99 percent of all people with a diagnosis of Diabetes in Scotland.¹ Because of the continuity of their medical records, combined with meticulous and focused diabetes record keeping, the SCI Diabetes database is the envy of most health care systems worldwide, as it is one of the best for diabetes research.

In the United States, the situation is fragmented with multiple health care providers each generating a medical record on the same patient, and no single provider is privy to the record of the others unless the patient agrees to make it available. Each medical record would likely differ in content, terminology, and verbiage due to each provider’s education, training, and experience. Because of this, research like what the Scottish group has done clearly would be impossible in the United States.

But wait, there is good news ahead. A technology called Natural Language Processing (NLP), a subfield of linguistics, computer science and artificial intelligence concerned with the interactions between computers and human language, will change the situation. NLP is the key to programing computers to process and analyze large amounts of natural language data and permits machine learning by computers.

I believe this new era of data mining from electronic medical records will become more frequently utilized in the future, and the data collected will provide more focused and clearer information on all aspects of health, including diabetic foot health. It may be possible that such data mining via electronic medical records could contribute to a decrease in the number of DFUs, amputations, and deaths. An additional, underappreciated value of using NLP and machine learning will be that one may be able to discover information previously not available or not considered in foot health management, including predictive analytics and a window through which to view the patient’s future health

Why Are These Systems So Important?

Since at present, the United States does not have the advantage of a single payer system medical record, nor does it have a SCI Diabetes-like database, we need to improve collection and evaluation of diabetic foot heath data. To that end, I believe there must be philosophical changes in how we evaluate and manage the foot health of the person with diabetes, and ultimately improve prevention of DFU’s, amputations and premature deaths.

In my experience, this begins with proactive/preventive (not reactive/treatment based) care. I believe we can implement this type of change by changing the medical business paradigm from fee-for-service to value-based care. In the fee-for-service model, providers receive reimbursement for treating pathology. In the value-based care model, providers receive reimbursement for preventing pathology and reducing the cost of care. The incentive for providers should point towards promoting health instead of treating sickness.

Secondly, I agree with researchers who suggest that every person with diabetes should have an annual diabetic foot exam to identify their unique risk factors for developing a foot ulcer.² This exam involves both a lower extremity-focused diabetes history and physical exam to gain information that will become invaluable for the development of the NLP and machine learning. This exam would be consistent with US Medicare guidelines and is a reimbursable service for evaluating diabetic patients with sensory neuropathy using codes G0245 for an initial exam and codes G0246 and G0247 for follow up exams.^3-5

The diabetic foot health history provides insights into potential issues of concern for ulceration or reulceration, amputation and death. As Podiatrists we know the diabetic foot physical exam focuses on identifying local risk factors for developing a foot ulcer, including peripheral arterial disease (PAD), diabetic sensory, motor, and autonomic neuropathies, bone, soft tissue, or nail issues. Once identified, patients with risk factors can receive appropriate treatment, advice, or referrals to help ameliorate the risk(s).

Considering the Impact of Mental Health and Prediabetes

Considering the research findings in the cited article, in addition to the usual patient evaluation criteria, the issues of mental illness and social deprivation are also crucial for patients with diabetes.¹

An article from Mental Health America identifies the following concerns about diabetes and mental health:

• increased risk for depression, anxiety and eating disorders for those with type 1 or type 2 diabetes.

• a two-times greater incidence of depression during the lifetime of those with diabetes compared to the general population.

• those with type 1 diabetes are twice as likely to live with disordered eating: and

• women with type 1 diabetes are more likely to experience bulimia, and women with type 2 diabetes are more likely to deal with binge eating.⁶

On the issue of social deprivation Michelle Lichtman, a researcher and Medical Director of the Intensive Diabetes Education and Support Program at the Utah Diabetes and Endocrinology Center, reports, “Higher still is the incidence of type 2 diabetes among minority and economically disadvantaged populations, when compared with non-Hispanic white people or the wealthy. Deaths from CVD among type 2 diabetes patients within those communities can be up to seven times greater than wealthier ones.”⁷

I also contend there is a need to more closely evaluate patients for unique risk factors for developing a foot ulcer when diagnosed with prediabetes, not waiting for a definitive diabetes diagnosis. At least one study shows that 25 to 62 percent of those with idiopathic peripheral neuropathy have prediabetes. Also, among patients that have prediabetes, 11 to 25 percent have peripheral neuropathy and 13 to 21 percent have nerve-related pain.⁸

Another study concluded that prediabetes carries a higher risk of microvascular disease and acute coronary syndrome, and that increased screening for vascular complications might allow clinicians to modify the significant rate of micro- and macrovascular disease in those with newly diagnosed type 2 diabetes.⁹

Failure to identify and treat risk factors such as these could contribute to the devastating comorbidities of diabetes that instead might benefit from early intervention, thus leading to less patient suffering and decreased health care expenses.

The Future of Diabetic Foot Ulcers and Their Sequalae

Patients need to be part of the solution, as well.  It is vital for every person with diabetes and their caregivers to receive education concerning their unique risks for developing a foot ulcer that can lead to amputation and untimely death and take steps to mitigate those risks. When appropriate, patients should visit a diabetes educator.¹⁰ Information on diabetes education is also available on the CDC website.¹¹ Risk mitigation starts with diabetes management and glycemic control. The new and exciting frontier of continuous glucose monitoring sensors (CGM) creates instantaneous awareness of blood glucose levels for patients and providers. Keeping blood glucose levels in the normal range is a vital strategy for preventing maturation of the comorbidities of diabetes to the feet, eyes, kidneys, cardiovascular system, brain, and oral cavity.

In the future, the patient health record will continue to provide vital information on the foot health of patients with diabetes. While Scotland devised a method to isolate and utilize data specific to diabetic foot health, the United States has not yet, making the tasks of decreasing ulcers, amputations, and diabetes related deaths more difficult.

Solutions to this challenge may lie in changes in the business model of health care toward value-based care/prevention, a yearly physician evaluation/ foot exam and appropriate management, early identification of risk factors for development of diabetic foot ulcers, better patient control of blood glucose levels via CGM monitoring, combined with more organized and standardized diabetic health records. The use of computers for machine learning combined with artificial intelligence will lead to predictive analytics and personalized medicine that has the potential to significantly reduce the incidence of DFUs, amputations, and death.

Dr. Hinkes is President and Chief Medical Officer of ePrevenir, Inc. He is board certified by the American Board of Foot and Ankle Surgery and is a Fellow of the American College of Foot and Ankle Surgeons and the American Professional Wound Care Association. He is the author of “Healthy Feet for People With Diabetes” and “Keep the Legs You Stand On,” available at www.amazon.com.

References

1. Chamberlain RC, Fleetwood K, Wild SH, et al. Foot ulcer and risk of lower extremity amputation or death in people with diabetes: a national population-based retrospective cohort study. Diabetes Care. 2022;45(1):81-91. https://doi.org/10.2337/dc21-1596

2. Boulton AJM, Armstrong DG, Albert SF, et al. Comprehensive foot examination and risk assessment: a report of the Task Force of the Foot Care Interest Group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care. 2008;31(8):1679-1685.

3. HCPCS Code G0245. HCPCS.codes website. Available at :  https://hcpcs.codes/g-codes/G0246/ . Accessed January 11, 2022.

4. HCPCS Code G0246. HCPCS.codes website. Available at:  https://hcpcs.codes/g-codes/G0246/ . Accessed January 11, 2022.

5. HCPCS Code G0246. HCPCS.codes website. Available at:  https://hcpcs.codes/g-codes/G0247/ . Accessed January 11, 2022.

6. Mental Health America. Diabetes and Mental Health. Available at: https://www.mhanational.org/diabetes-and-mental-health . Accessed January 21, 2022.

7. Not all patients with diabetes are treated equally. Scientific American. https://www.scientificamerican.com/custom-media/not-all-patients-with-diabetes-are-treated-equally/ . Accessed January 21, 2022.

8.  Papanas N, Vinik AI, Ziegler D. Peripheral neuropathy in prediabetes: does the clock start clicking early? Nat Rev Endocrinol. 2011;7(11):682-690. doi: 10.1038/nrendo.2011.113.

9. Palladino R, Tabak AG, Khunti K, et al. Association between pre-diabetes and microvascular and macrovascular disease in newly diagnosed type 2 diabetes. BMJ Open Diabetes Res Care. 2020:8:e001061.

10.  American Diabetes Association. Find a diabetes education program in your area. Available at: https://www.diabetes.org/diabetes/find-a-program . Accessed January 21, 2022.

11. Centers for Disease Control and Prevention. Education and support. Available at: https://www.cdc.gov/diabetes/managing/education.html . Accessed January 21, 2022.