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Factoring Patient Goals And Expectations Into Our EBM-Based Protocols For Patients With Diabetes
Evidence-based medicine (EBM) is defined as “the conscientious, explicit, judicious use of the best current evidence combined with clinical expertise and patient values in making decisions about care of individual patients.”1 The triad of what is known through research, what has been experienced by the provider and what the patient desires should help guide therapy and the treatment course. This is especially the case when one is addressing complicated conditions such as limb-threatening ischemia or infections.
We must consider each point of the triad equally but often clinicians do not adequately explore the patient’s goals and expectations. As physicians, we see a lab value out of range and we want to correct it. We see signs of osteomyelitis on imaging and we consider medical management or surgical resection. When there is a blockage on arteriograms, the tendency is to try to fix it, either through open or percutaneous procedures. The challenge for us as clinicians is treating the patient, not the lab value or an imaging study.
The “nibble effect” is still one that our patients fear and may be a cause of delaying presentation. Many patients are afraid that once they lose a toe, it will progress to a partial foot amputation and subsequently result in a major amputation in rapid sequence. From the clinician side, we are also well aware of the benefits of distal limb salvage both from an improved morbidity and mortality perspective in comparison to major amputations.2 Accurate prediction of successful outcomes is an elusive quest for the healthcare team and can result in dramatic, life-changing events for our patients.
Recognizing The Costs Of Limb Salvage Procedures In High-Risk Patient Populations
The cost of caring for people with diabetes as well as the associated complications is expensive. Some propose that if the eventual result for these patients will be proximal amputation, performing a primary procedure would save the healthcare system money and enable the patient to move on with his or her life in an expeditious fashion. Limb salvage attempts in the acute situation may require expensive interventions such as acute and/or prolonged hospitalization for IV antibiotic therapy, surgical revascularization procedures and advanced wound care modalities such as hyperbaric oxygen therapy (HBOT).
In 2014, Malone and colleagues published an article entitled, “The Effect of Diabetes Mellitus on Costs and Length of Stay in Patients with Peripheral Arterial Disease Undergoing Vascular Surgery.”3 The study explores inpatient costs of treating peripheral arterial disease (PAD) in patients with and without diabetes. Results from this study revealed that caring for people with diabetes and PAD cost an additional $1,912 per patient per hospitalization in comparison to those with PAD alone. Over 18 months, this resulted in an additional expense of $528,029 for the hospital system.
The majority of this expenditure was attributed to additional inpatient days.3 Among those with PAD and diabetes undergoing surgical revascularization, the average hospital stay required was 15 days versus 10 days for those without diabetes.
Examining Predictive Factors For Limb Salvage Surgery Outcomes
Researchers have dedicated a fair amount of research to predicting healing outcomes in patients with diabetic foot ulcers based on perioperative objective findings. Ensuring an optimal amputation level preserves as much limb length as possible and helps reduce the risk of further re-amputation.
Choi and coworkers published on predictive factors for successful limb salvage surgery in patients with diabetes.4 In this retrospective review, the authors looked at 154 patients who had limb salvage surgery for distal foot gangrene. Then the study authors assessed those who achieved healing and those who failed to heal the primary limb salvage surgery. They looked at many variables as predictors of success including demographic information, comorbidities, laboratory findings and radiographic findings. Their statistical analysis showed that underlying renal disease, limited activity before surgery, a low hemoglobin level, a high white blood cell count, a high C-reactive protein level, and damage to two or more vessels on preoperative computed tomography (CT) angiogram were significantly associated with the success or failure of limb salvage. Additionally, Choi and colleagues reported five-year survival rates of 81.6 percent for the limb salvage success group and 36.4 percent for the limb salvage failure group.
The conclusion from this study revealed the importance for the surgeon to critically examine the significant predictors of limb salvage surgery in an effort to prevent costly subsequent surgeries. Unfortunately, nowhere in this study did the researchers explore the patients’ goals, desires and perceptions of their outcomes.
When Multiple Procedures Fail To Prevent The Amputation: What A Study Reveals About The Patient Perspective
Researchers have paid little attention to the patient perspective in limb salvage surgery research. In 2008, Reed and colleagues published an article in the Annals of Vascular Surgery titled “Major Lower Extremity Amputation After Multiple Revascularizations: Was It Worth It?”5 The purpose of this study was to investigate the patients’ perspectives of multiple procedures for limb salvage that culminated in major lower extremity amputation. In other words, these patients were facing limb-threatening ischemia and the question was to perform primary high-level amputation or attempt limb salvage through revascularization efforts. Between January 2000 and December 2005, the authors performed 78 major (below-knee or above-knee) amputations at their facility. They followed these patients for an average of five years after the high-level amputations, which were preceded by an attempt at surgical revascularization.
Reed and coworkers noted several interesting results in this study.5 First, they had a 59 percent survival rate at the average five-year follow-up. After losing 13 patients to follow-up, they had data for 33 patients, who they were able to query via telephone interview as well as questionnaires to get their reflections on their experience including multiple attempts at revascularization that were ultimately unsuccessful limb salvage attempts resulting in major amputations. Among these 33 patients, there was a total of 142 revascularization procedures, yielding an average of four procedures per patient. Interestingly, there were 94 open procedures and 42 percutaneous interventions among this cohort. The study also found that 18/33 (54 percent) of patients in the study actively used a prosthesis and 30/33 (91 percent) resided at home at the time of follow up. Eighty-five percent (28/33) of amputees surveyed stated they would do everything to save the leg if faced with a similar scenario, regardless of the number of procedures. One can conclude from this study that despite the possibility of a potentially poor outcome, the clear majority of patients want every attempt for a chance at limb salvage. The concept of “no stone unturned” resonates with this patient population.
Every patient scenario is unique and options for treatment will vary. Each patient presents with a different set of comorbidities and psychosocial attributes. Accordingly, one should explore patient goals and desires at every patient encounter. Asking open-ended questions and listening will help guide the treatment course, and this is actually an important part of the practice of EBM. Ultimately, we seek to provide clinically effective outcomes with the goals of preserving functionality and quality of life. Clinical efficacy will yield cost efficacy for our healthcare systems. Practicing EBM in these situations must include knowledge of research outcomes, provider experience with this patient population and active involvement of patients in the process.
Our goal at the end of the day should be to provide the patient with the best possible outcome he or she desires. In a patient population with known advanced morbidity and mortality, this concept is even more important, and is not unlike the quality of life discussions oncologists have with their cancer patients. In general, the mantra for limb salvage supported by both providers and patients should be “toe before foot, foot before leg and leg before life.”
Dr. Rothenberg is a Clinical Assistant Professor of Internal Medicine with the University of Michigan School of Medicine in Ann Arbor, Mich.
References
1. Sackett DL, Rosenberg WM, Gray JA, et al. Evidence based medicine: what it is and what it isn’t. Br Med J. 1996;312(7023):71-2.
2. Larsson J, Agardh CD, Apelqvist J, Stenström A. Long-term prognosis after healed amputation in patients with diabetes. Clin Orthop Relat Res. 1998;350:149-58.
3. Malone M, Lau NS, White J, et al. The effect of diabetes mellitus on costs and length of stay in patients with peripheral arterial disease undergoing vascular surgery. Euro J Vasc Endovasc Surg. 2014;48(4):447–451.
4. Choi MSS, Jeon SB, Lee JH. Predictive factors for successful limb salvage surgery in diabetic foot patients. BMC Surg. 2014;14:113.
5. Reed AB, Delvecchio C, Giglia JS. Major lower extremity amputation after multiple revascularization: was it worth it? Ann Vasc Surg. 2008;22(3):335-340.
