A recent article entitled “A Review of Brace Adherence Monitoring Methods” caught my eye because I own a brace company and I am particularly intrigued with studies of patient adherence with various immobilizing devices.1 This article, authored by Thatipelli and coworkers, analyzed 19 published studies that evaluated adherence rates and monitoring systems in scoliosis, clubfoot, ankle and knee immobilizer bracing treatments. The adherence by patients to follow instructions for brace usage was incredibly low for all types of braces.
Overall, this review demonstrated that clubfoot braces have a non-adherence rate ranging from 27 to 45 percent.1 Scoliosis braces have a similar non-adherence rate ranging from 27 to 45 percent with one study showing that patients only wore their scoliosis braces for less than two hours per day.1
The authors of the aforementioned review recommend real time monitoring of patients who require long-term bracing, using either pressure sensitive sensors or temperature sensitive sensors that are attached to the brace.1 They point to several studies using brace sensor monitoring that show a significant discrepancy between what patients report and what actually occurred with adherence to the prescribed brace usage. When doctors told patients they were being monitored for daily use of their brace, adherence improved. The authors propose that monitoring may improve adherence and thus improve treatment outcome.
In regard to monitoring, many of us are aware of a previous study of patients with diabetes with active ulceration who got instructions to wear a protective walking boot at all times during ambulation.2 With a hidden pedometer embedded in the walking boot, Armstrong and coworkers were able to determine that these patients with active ulcers only wore their prescribed offloading boots 29 percent of the time they were on their feet.
I did a little more searching and found a related article entitled “Compliance of Patients Wearing an Orthotic Device or Orthopedic Shoes: a Systematic Review.”3 This review evaluated ten published studies of 1,576 patients wearing various types of lower extremity orthoses, such as ankle foot orthoses (AFOs) and foot orthoses. The review included several studies looking at compliance with custom orthopedic shoes. Compliance with braces or shoes was extremely low, ranging from 6 to 80 percent of non-use of the prescribed devices. Orthopedic shoes had up to 25 percent non-compliance while bilateral dropfoot AFO devices had 80 percent non-compliance in one study. The researchers concluded that non-compliance translates directly to financial loss with decreased therapeutic benefit.
A study by Swinnen and colleagues revealed the reasons why patients are non-compliant with bracing and orthopedic shoes.3 The primary reason for discontinuing use of braces or prescribed shoes is aesthetic unacceptability. Also, if the patients did not see noticeable improvement in walking function or mobility, or if they could manage without the brace or shoe, then compliance with the device dropped off.
In my own experience treating patients with various types of braces and immobilizing devices, I have learned there is better patient compliance with certain conditions. Posterior tibial tendon dysfunction (PTTD) has a high compliance rate of brace usage simply because patients feel immediate pain relief and improved mobility. Dropfoot patients may feel better stability with their AFO but also will often risk injury and walk in the house without their AFO. Patients with diabetes who use offloading footwear or walking boots have the lowest compliance. They do not experience pain relief and often feel less stable in gait due the restrictive effects of the devices compounding the balance disorder that accompanies neuropathy.4
Thatipelli and colleagues point out the effects of non-adherence on the total cost of healthcare.1 They cite two studies of medication non-adherence, which places an additional burden of $300 billion per year to heathcare costs.5,6 With chronic medical therapy, clinicians expect that only 50 percent of patients will follow through with completion of treatment in the first year.7
An interesting insight gained from reviewing these papers is a proposed difference between the terms “adherence” and “compliance.” One study (Thatipelli) used the word “adherence” while another study (Swinnen) chose the word “compliance” to describe the use or disuse of prescribed braces.1,3
We commonly use compliance or non-compliance in the podiatric profession to describe appropriate or inappropriate patient behavior. We do not see the term “adherence” used very much in podiatric literature. Yet “adherence” is a more appropriate behavior, which we should expect from our patients who have a prescription for long-term treatment.
In reviewing the study by Thatipelli and colleagues as well as an editorial by Jeffrey K. Aronson, the Editor-in Chief of the British Journal of Clinical Pharmacology, one can appreciate the subtle differences between the behaviors described by the terms “compliance” versus “adherence.”1,8 Adherence is an active choice of patients to follow through with the prescribed treatment while taking responsibility for their own well-being. Compliance is a passive behavior in which a patient is following a list of instructions from the doctor. Adherence is a more positive, proactive behavior, which results in a lifestyle change by the patient, who must follow a daily regimen such as wearing a prescribed brace. In contrast, compliance is a behavior exhibited by a patient who is simply “doing as (he or she is) told” or following a list instructions given by the treating doctor.
For example, a postoperative patient may receive instructions for strict non-weightbearing after a Lapidus bunionectomy. The patient would be expected to “comply” with this order for a limited period of time. On the other hand, a patient with diabetes at risk for ulceration would get instructions to make specific lifestyle changes such as the daily use of therapeutic footwear. Adherence to this lifestyle change requires that the patient make a conscious daily decision to wear the prescribed shoes, adopting a new behavior that must continue for a lifetime.
When prescribing long-term therapy such as AFO intervention for PTTD, podiatric physicians should evaluate their role in teaching patients to make lifestyle changes that are essential to their well-being. Instead of giving a list of “Do’s and Don’ts,” we should help empower our patients to make positive change and actively participate in their treatment. This active participation by patients involves making a daily decision to wear their braces and perhaps carry out certain exercises that are essential to achieving a positive outcome. This active participation by patients in their treatment demonstrates a positive behavior of “adherence” in comparison to the negative or passive behavior of being “compliant.” Perhaps that is why it is a lot easier for a patient to be “non-compliant” than “non-adherent.”
1. Thatipelli S, Arun A, Chung P, Etemadi M. et al. A review of brace adherence monitoring methods. J Prosthet Orthotics. 2016; 28(4):126–35.
2. Armstrong DG, Lavery LA, Kimbriel HR, et al. Activity patterns of patients with diabetic foot ulceration: patients with active ulceration may not adhere to a standard pressure off-loading regimen. Diabetes Care. 2003; 26(9):2595–7.
3. Swinnen E, Kerckhofs E. Compliance of patients wearing an orthotic device or orthopedic shoes: A systematic review. J Bodywork Movement Ther. 2015; 19(4):759-770.
4. Lavery LA, Fleishli JG, Laughlin TJ, Vela SA, Lavery DC, Armstrong DG. Is postural instability exacerbated by off-loading devices in high risk diabetics with foot ulcers? Ostomy Wound Manage. 1998; 44(1):26-32,34.
5. Wertheimer AI. Medication compliance research: still so far to go. J Appl Res. 2003;3(3):254–261.
6. Hasford J. Biometric issues in measuring and analyzing partial compliance in clinical trials. In: Patient Compliance in Medical Practice and Clinical Trials. Raven Press, New York, 1991, pp. 265–282.
7. Besch CL. Compliance in clinical trials. AIDS. 1995; 9(1):1–10.
8. Aronson J. Compliance, concordance, adherence. Br J Clin Pharmacol. 2007; 63(4):383–384.