Evidence-based medicine (EBM) is becoming an essential component of O&P practice. In simplest terms, EBM is discontinuing practices that medical evidence demonstrates do not improve clinical outcomes, and conversely, consistently incorporating into practice interventions that are proven to enhance patient outcomes.
EBM was introduced in the 1990s and defined as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of the individual patient.”1 An article titled “The Value of Traditional Reviews in the Era of Systematic Reviewing” extolled the virtues of narrative and integrative reviews, including their critically important contribution to the establishment of evidence-based clinical practice guidelines.2 In prosthetics, the care of individuals with transtibial amputations is a natural focus for EBM practice recommendations. Medical evidence demonstrates that four overarching factors influence successful outcomes following lower-limb amputations. They are surgical technique; post-operative care; site of discharge; and amount, intensity, and duration of physical therapy. Two clinically important components of post-operative care are peer support and post-operative dressing choice.
An integrative review was published this year in the Journal of Vascular Nursing that examined the extant body of evidence regarding the value of peer support for people with major limb amputations.3 Researchers assembled ten peer-reviewed studies published from 1977 to 2009 on amputee peer support, including one level III retrospective case-controlled trial, two level IV case series, and seven level V expert opinions.4-13 They found that all the studies demonstrated or described improved outcomes as a result of a peer support visit. In fact, 92 percent of patients surveyed responded favorably to a peer visit and claimed it substantially improved their amputation outlook after surgery.5 Over 50 percent of patients would have liked an additional peer visit during their rehabilitation, and 66 percent of patients older than 65 and 70 percent of people with bilateral amputations said they desired even more peer visits.7 The authors of the review concluded that, although the research designs of the various studies were not particularly robust, the totality of the evidence is one directional. Peer support intervention is low cost and low risk. The resulting evidence-based clinical practice recommendation is that all individuals undergoing major limb amputations should be offered peer visits as a post-operative component of the rehabilitation process.
Traditionally four types of post-operative dressings are applied to individuals’ residual limbs following transtibial amputations. Soft dressings, typified by elastic bandage or shrinkers, are the most common and have the advantages of low cost and ease of donning and doffing. However, most prosthetists have had the experience of patients arriving for appointments with their soft dressing misapplied, either too tight, causing skin breakdown, or too loose, allowing edema and a misshapen limb. Plaster casts or rigid dressings (RD) became the standard of practice in the 1970s for orthopedists. Through the use of rigid dressings, patients and prosthetists ultimately experienced well-shaped limbs that were quickly prepared for a prosthesis. The immediate post-operative prosthesis (IPOP) is a rigid dressing technique that incorporates the advantages of a plaster cast and limited weight bearing on the limb soon after surgery. The psychological advantage of getting patients up quickly cannot be overestimated, but the risk of falls and the inability to gauge the amount of pressure make an IPOP risky for many patients in the eyes of today’s surgical teams. IPOP or RD post-surgical care is still used, however it is generally ordered only by orthopedists and many times is reserved for young people with traumatic amputations, such as war veterans and athletes.
IPOPs or RDs are also viable options for amputations that are a result of vascular insufficiency. RDs provide the benefits of removable ridged dressings (RRDs), except ease of wound inspection, which according to most surgical and hospital protocols, makes them impractical for patients receiving amputations for ischemic disease who are at high risk of developing wound dehiscence. While actual cases of infection after removal of a RD are not well documented in the journals of many surgical specialties, the primary strategy for minimizing infection is visual inspection of the wound and using any form of rigid dressing remains limited for fear of infection.
RRDs were developed to capture all the advantages of the plaster cast or rigid dressing while eliminating the overwhelming disadvantage of no immediate wound inspection. Therefore, the RRD protocol is much better received because it facilitates limb maturation with easy donning and doffing for frequent inspection and treatment of the surgical wound.
Removable Rigid Dressings
A review of the evidence regarding removable rigid dressings was recently published in the PM&R Journal.14 Each piece of evidence was assigned a level based on the research design of the study utilizing the scale recommended by the PM&R Journal (level I through V).15 The extensive search uncovered 15 articles, including five level I randomized controlled trials (RCT), six level III retrospective matched controlled trials, and four level V case reports. The authors reviewed the published medical evidence regarding the use of RRDs as a post-operative management strategy, culminating in an evidence-based practice recommendation for their use.
Forty years of clinical experience and peer-reviewed research support the use of non-weight bearing RRDs as an effective means of post-operative management of transtibial amputations. RRDs are proven to improve the outcomes of patients following transtibial amputations and yet remain underutilized. The benefits associated with the application of RRDs included faster healing times, reduced limb edema, preparatory contouring of the residual limb in anticipation of prosthetic use, the prevention of knee flexion contracture, and reduced external trauma to the limb. Also described was an increased probability of successful prosthetic use and pain reduction. The RRDs studied permitted regular inspection of surgical wounds with greater ease and consistency of application than traditional soft dressing approaches. The benefits of RRDs are universally recognized in the published peer-reviewed medical evidence to be superior to soft dressings and based on the best available current evidence; non-weight bearing removable rigid dressing should be considered the first treatment choice for the post-operative care of patients with transtibial amputations to optimize outcomes. Specifically, areas of improved outcomes were reductions in amputation injury due to falls, knee flexion contractures, edema, healing time, time to prosthetic fitting, and pain. RRDs can be individually fabricated for a specific patient or they can be prefabricated designs. No evidence exists demonstrating that patient-specific custom devices outcomes are superior to prefabricated RRDs. Prefabricated RRDs come in several sizes and can accommodate roughly 85 percent of all individuals with transtibial amputations. A clear advantage of prefabricated RRDs is that they can be fitted quickly while the patient is in recovery, and therefore have the earliest impact on edema, limb contouring, pain reduction, and protection from falls.
Hospital falls gained increased attention when Medicare decided to financially penalize hospitals for avoidable falls. Patients who have undergone amputation surgery represent the subset of patients who are most likely to experience an inpatient fall. Twenty percent of amputees fall in an acute care institution, i.e. the hospital or inpatient rehabilitation center; more than the 17 percent of stroke patients who fall in the same setting.16 Three percent of people with lower-limb amputations experience a fall that requires a revision surgery.17 Tragically, almost half of patients who require a revision surgery experience a transfemoral amputation as a final outcome.18 Evidence demonstrates that falls requiring a return for revision surgery are eliminated when patients are wearing a properly fitted RRD.17
RRDs are well documented in the literature, however the evidence is published in multiple journals and across various surgical and rehabilitation specialties, creating a challenge for prosthetists in educating physicians about their effectiveness. Also, to provide the best outcome, an RRD should be applied as soon as possible after amputation, ideally while the patient is in recovery. However, providers who bill Medicare under durable medical equipment, prosthetics, orthotics, and supplies rules operate under the two-day rule, which mandates that to be reimbursed directly, a supplier must deliver the RRD to the beneficiary no earlier than two days before hospital discharge. Since the hospital length of stay for an amputation will extend beyond two days, the RRD is included in the hospital’s diagnostic-related grouping for billing and becomes a cost to the hospital. For that reason, hospitals may limit RRDs unless practitioners use medical evidence to substantiate that the device will reduce the acute length of stay and protect the patient from injury due to falls, which more than offsets the device cost. On the other hand, many managed care organizations recognize that RRDs protect against falls and have been proven to shorten acute length of stay and will often separately reimburse the prosthetist for the post-operative device.19
Outcomes measurement is a critical step necessary to effectively practice EBM. Fortunately, in prosthetics the outcome to collect is fairly obvious—mobility. But exactly how to measure mobility may not be quite so clear. A strong positive correlation between mobility and quality of life and general satisfaction is unsurprising. Using goal attainment scaling (GAS), researchers have previously determined that mobility is the primary concern of people with a lower-limb amputation, so it seems reasonable to measure mobility.20 It is also generally accepted that rising, sitting down, and climbing stairs can be particularly challenging for this population. Since mobility is of great concern for people with lower-limb loss and important to recovery, the timely, consistent, and accurate measurement of mobility becomes paramount in the practice of EBM and management of the rehabilitation process.
Mobility measurement can be performed through questionnaires (perception), physical tests (capacity), or activity monitors (performance).21 Unfortunately, agreement between perception, capacity, and performance is quite poor.22-23 Certainly O&P organizations can capture patients’ perception by having them complete questionnaires like the Prosthetic Limb Users Survey of Mobility and the Prosthesis Evaluation Questionnaire – Well Being and provide those to referring physicians. If a patient is in the office, it seems reasonable to measure his or her mobility capacity with a test like the Timed Up and Go or Amputee Mobility Predictor. Or better yet, have the patient do a performance test to determine how well he or she rises, sits, and walks up and down steps, and report that back to the clinician managing the patient’s rehabilitation. Whatever the measure, an important aspect of EBM for prosthetists is to routinely perform the measurements with patients and review the results with the referring physicians.
A February 2018 article in The O&P EDGE titled “Evidence-based Practice: Do the Rules Apply to Us?” concluded that the goal should be to use all evidence available to make the best practice decision possible.24 Clearly the post-operative care of patients immediately following amputation offers an opportunity to actualize that goal. Collecting and reporting outcomes is not enough. Clinicians must critically examine current clinical practices on an ongoing basis to identify and eliminate those that are routinely being performed for which there is not good supporting evidence. Lastly, clinicians should practice EBM and consistently perform outcome enhancing interventions that are conclusively supported by published peer-reviewed evidence. One such clear example that exists in O&P is the post-operative dressing choice for transtibial amputees. This is a high-impact area as it relates to outcomes because the majority of lower-limb amputations are at the transtibial level, and a high proportion of those who wear prostheses have transtibial amputations. The post-amputation goal is well accepted: attempt to return the patient to his or her pre-amputation activity levels. Secondarily, since the introduction of hospital incentives to reduce hospital-acquired conditions included in the Hospital-Acquired Condition Reduction Program component of the Patient Protection and Affordable Care Act, RRDs have become more attractive to hospital systems that desire to prevent limb injury from a fall.
Another evidence-based intervention proven conclusively in the medical literature is amputee peer support, which literature supports offering to all patients who undergo amputation. Peer support is low cost, has low potential for harm, and evidence demonstrates outcome improvement. Peer support requires few resources and can be easily arranged through national or local amputee support groups. Evidence demonstrates that RRDs and peer support improve the outcomes of individuals with amputations. Now is the time to dedicate attention to putting the medical evidence on post-operative care of the recent amputee into practice.
James P. Reichmann, MBA, was formerly vice president of sales and marketing, Hanger Clinic, Austin, Texas, and has published 15 peer-reviewed articles in a variety of healthcare fields. He is currently pursuing a Master of Public Health degree at Georgia State University. Reichmann can be contacted at [email protected].
Alfred E. Kritter, CPO, FAAOP, recently retired as the chief compliance officer, Hanger Clinic, and has served in numerous roles in O&P associations. Kritter is a practicing consultant.