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VOLUME 4, ISSUE 2  
 2021 

 

STAKEHOLDER  PERSPECTIVES 

Miller TA, Wurdeman S, Paul R, Forthofer M. The value of health economics and outcomes research in prosthetics and orthotics. Canadian Prosthetics & 

Orthotics Journal. 2021; Volume 4, Issue 2, No.8. https://doi.org/10.33137/cpoj.v4i2.35959 

This article has been invited and reviewed by Co-Editor-In-Chief, Dr. Silvia Ursula Raschke. 
English proofread by: Karin Ryan, M.A., B.Sc., P.T. 
Managing Editor: Dr. Hossein Gholizadeh 
 

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Miller TA, Wurdeman S, Paul R, Forthofer M. The value of health economics and outcomes research in prosthetics and orthotics. Canadian Prosthetics & Orthotics 
Journal. 2021; Volume 4, Issue 2, No.8. https://doi.org/10.33137/cpoj.v4i2.35959 

 

 

 
STAKEHOLDER  PERSPECTIVES 

 

THE VALUE OF HEALTH ECONOMICS AND OUTCOMES RESEARCH IN PROSTHETICS AND 

ORTHOTICS 

Miller TA.1,2 *, Wurdeman S.1,3, Paul R.4, Forthofer M.2  
 

1 Department of Clinical and Scientific Affairs, Hanger Clinic, Austin, Texas, USA. 
2 College of Health and Human Services, University of North Carolina at Charlotte, Charlotte, North Carolina, USA. 
3 Department of Biomechanics, The University of Nebraska at Omaha, Omaha, Nebraska, USA.   
4 Department of Public Health Sciences, School of Data Science, University of North Carolina Charlotte, North Carolina, USA.  

 

 

 

 

  

 

 

 

 

 

INTRODUCTION 

Rehabilitation is can be defined as a problem-solving 

process or service aimed at reducing disability or 

impairment experienced by an individual as a result of 

disability or injury ultimately to improve function.1,2 Unmet 

needs for rehabilitation services and health systems are 

often undervalued services.2,3 Individuals who have a lower 

limb amputation (LLA) or require orthotic bracing 

experience numerous, overlapping difficulties with respect 

to overall physical health including functional recovery  

as well as social and mental health.4-7 As healthcare costs 

have increased, the economic burden associated  

with care for those with chronic conditions, especially 

functional impairment and disability, remains high.8-11  

Rehabilitation is essential if individuals are to regain 

functional independence, return to ADLs and good  

overall health whether it be in a post-amputation condition 

or a progressive neuromusculoskeletal condition. Yet, real- 

 

world evidence (RWE) on rehabilitation outcomes among 

those with LLA and neuromusculoskeletal conditions 

requiring orthotic intervention is sparse. There is a paucity 

of information relating to timing of orthosis or prosthesis 

receipt in the care pathway, effectiveness of interventions, 

overall costs and utilization. Hence, there is a need for more 

RWE on factors that influence outcomes to help inform 

clinical practice and guide clinicians, strengthen policy, and 

influence patient-health while being cost-effective.12,13 The 

purpose of this paper is to explicate health economics and 

outcomes research (HEOR) as a field, discuss recent 

applications in orthotics and prosthetics (O&P), and the 

need for continued health economic research. 

Recent publications on economic science provided 

perspectives from consumers, providers, and 

manufacturers,14-16 which highlighted that health economic 

analyses and science is not about reducing access to 

essential O&P care but to optimize outcomes and access. 

Healthcare decision makers today are often faced with the 

need to select from multiple treatment options, the timing of 

any such treatment, or determine alternative appropriate 

care plans. However, the benefits and associated costs of 

these different interventions or plans can vary greatly. The 

 
OPEN  ACCESS Volume 4, Issue 2, Article No.8. 2021 

 

 

Journal Homepage: https://jps.library.utoronto.ca/index.php/cpoj/index 

 

ABSTRACT 

The demand has increased for evidence regarding the effectiveness and value of 

prosthetic and orthotic rehabilitation interventions. Clinicians and managers are under 

pressure to provide treatment recommendations and demonstrate effectiveness through 

outcomes. It is often assumed that rehabilitation interventions, including the provision of 

custom-made and custom-fit orthotic and prosthetic devices, are beneficial to patients. 

Assessing the value of orthotic and prosthetic services has become more critical to 

continue to ensure equitable access to needed services. Health economics and 

outcomes research methods serve as tools to gauge the value of prosthetic and orthotic 

rehabilitation interventions. The purpose of this article is to provide an overview of the 

current need of health economics and outcomes research in orthotics and prosthetics, to 

introduce common economic methods that assist to generate real-world evidence, and 

to discusses the potential value of economic methods for clinicians and clinical practice.  

CITATION 

Miller T.A, Wurdeman S, Paul R, Forthofer M. The 

value of health economics and outcomes research 

in prosthetics and orthotics. Canadian Prosthetics 

& Orthotics Journal. 2021; Volume 4, Issue 2, 

No.8. https://doi.org/10.33137/cpoj.v4i2.35959 

KEYWORDS 

Health Economics, Prosthetics, Orthotics, 

Outcomes Research, Rehabilitation 

 

 

* CORRESPONDING AUTHOR 

Taavy A Miller, PhD, CPO 

Department of Clinical and Scientific Affairs, Hanger Clinic, Austin, 
Texas, USA. 
E-Mail: tamiller@hanger.com 

ORCID ID: https://orcid.org/0000-0001-7117-6124 

Special Issue: Health Economics in Prosthetics & Orthotics 

https://doi.org/10.33137/cpoj.v4i2.35959
https://jps.library.utoronto.ca/index.php/cpoj/index
https://doi.org/10.33137/cpoj.v4i2.35959
mailto:tamiller@hanger.com
https://orcid.org/0000-0001-7117-6124


 

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Miller TA, Wurdeman S, Paul R, Forthofer M. The value of health economics and outcomes research in prosthetics and orthotics. Canadian Prosthetics & Orthotics 
Journal. 2021; Volume 4, Issue 2, No.8. https://doi.org/10.33137/cpoj.v4i2.35959 

ISSN: 2561-987X 
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benefits can be clinical, economic, or may include more 

humanistic outcomes. Humanistic outcomes, such as 

patient experiences, are more challenging to measure as 

they cannot be evaluated by clinicians but rather are patient-

reported (e.g. pain and quality of life). HEOR applications 

(i.e. types of economic evaluations) include broad, 

scientifically vigorous methods and tools used to assess the 

effectiveness and impact of specific interventions (e.g. 

specific knee selection) in order to adequately compare and 

choose treatments or devices among the available options 

(Table 1).  

Table 1: Examples of the basic types of economic evaluations and 

preference-based analyses with applications in O&P or related 

rehabilitation literature.  

Type of 
evaluation 

Definition Example in literature 

Cost-
effectiveness 
analysis (CEA) 

A comparison between 
the costs and an 
outcome for a specific 
treatment or 
intervention (e.g. the 
cost of providing a 
prosthesis or orthosis 
compared to not 
providing one) 

Dobson, DaVanzo & 
Associates LLC: cost 
effectiveness of 
prosthesis among 

Medicare beneficiaries17 

Cost utility 
analysis (CUA) 

Often referred to as a 
sub-type of CEA; 
specifically, an analysis 
that includes health 
utility (i.e. health related 
quality of life or quality 
adjusted life 
year/QALY) 

Gerzeli et al: Cost utility 
analysis comparing 
different microprocessor 
knees among working-

age patients in Italy18  

Cost benefit 
analysis (CBA) 

An alternative to CEA, 
monetary value is 

placed on both costs of 
treatment and 
effectiveness; all costs 
(i.e. direct and indirect) 
are considered 

Glassman et al.: costs 
and benefits (outcomes) 
of several non-surgical 
treatments compared for 

adult scoliosis19 

Cost 
minimization 
analysis 
 

An analysis conducted 
to identify a least costly 
alternative of effective 
treatment (e.g. tele-
rehabilitation versus 
face to face) 

*unable to identify a 
specific O&P example 

Cost-
consequence 

An analysis used to 
describe an intervention 
or compare two or more 
interventions including 
the effect of costs and 
outcomes  

Gil et al: Cost 
comparison of limb 
salvage versus 

amputation20
 and 

Edwards et al.: Markov 
model assessing cost 
consequence of 
prosthetic 

rehabilitation21  

Multi-criteria 
decision 
analysis or 
discrete choice 
experiment 
(preference 
studies) 

A structured process for 
making decisions and is 
a tool that can extend 
traditional economic 
analysis methods to 
include the patient 
perspective and assist 
with prioritization of 
healthcare interventions 

Geidl et al: Assessing 
exercise preferences for 

patients after a stroke22  

Previous work has demonstrated that it is possible to assess 

healthcare resource utilization and costs through the use of 

a population-based, nationally validated claims dataset 

while providing meaningful insight into clinical care and 

patient outcomes.17,23 Furthermore, decision-making based 

on the preferences of patients (e.g. health state preference, 

utility) along with traditional economic analyses (e.g. cost-

effectiveness studies) will contribute to optimizing patient 

outcomes. These types of health economic concepts are 

important to understand as the O&P practitioner and key 

stakeholders are continuing to navigate the increasingly 

challenging demands of the healthcare system.  

Rehabilitation services  

Currently, there is limited evidence in O&P rehabilitation 

regarding outcome factors related to delivery of care such 

as patient preferences, accessibility and timing of provision, 

economic impact and value of rehabilitation services for 

people with functional impairment or decreased mobility.24 

Without adequate evidence on the performance and 

effectiveness of O&P rehabilitation treatment, scrutiny of 

services will continue by policymakers and payers, 

potentially resulting in reduced access to needed services.2  

Physical medicine and rehabilitation service is a broad 

category in healthcare targeting a wide population (children, 

adults, and older people) with a range of conditions 

impacting function and participation, including diverse 

interventions (rehabilitation medicine, orthopedic surgery, 

physical therapy, occupational therapy, prosthetics, 

orthotics, and assistive devices) and outcomes.25 The 

primary goal of physical rehabilitation services is to address 

individual needs towards the reduction of symptoms and to 

promote independence in daily activities or participation,26 

which includes predisposing (e.g. demographic 

characteristics such as amputation level), enabling (e.g. 

environmental, social, health insurance status), and need 

(e.g. modifiable health status such as comorbid health 

conditions) factors, which each contribute towards overall 

rehabilitation use.2,27 

Clinical and policy decisions about appropriate and optimal 

rehabilitation interventions require evidence on resource 

allocation, costs and effectiveness.25 Rehabilitation 

services are often undervalued by health systems due to 

being under-funded, under-researched and under-provided 

in many contexts.2,25 Lack of evidence and knowledge on 

patient outcomes due to physical rehabilitation services 

result in reduced access to appropriate services, which 

includes access to assistive devices (e.g. orthoses and 

prostheses) and physical therapy.28,29  

 

 

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Journal. 2021; Volume 4, Issue 2, No.8. https://doi.org/10.33137/cpoj.v4i2.35959 

ISSN: 2561-987X 
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Lack of understanding of value of prosthetic 

rehabilitation 

The demand for value-based care in rehabilitation is 

growing while the concept of value is multidimensional and 

may be defined differently depending on the stakeholder 

(e.g. patient, payer, provider or society). The traditional 

economic definition of value is dependent on cost, quality 

and willingness to pay for a good or service.12 The 

components that comprise how we gauge the value of an 

intervention or healthcare service is based on perspective, 

whether societal or individual, as well as cultural 

perceptions.12,17 Therefore, it is important to assess health 

interventions and resultant outcomes (functional health or 

economic) within the context of a single country or region. 

The approach to place value and quantify treatment effects 

is more widely being applied with payers and policymakers 

asking for evidence.8,17 The field of physical rehabilitation 

has perhaps fallen behind other services in the amount of 

value-based evidence.2,13 O&P care, a niche subset within 

physical rehabilitation, has arguably fallen even further 

behind. It is critical that as a field, - we collaboratively work 

to gauge value based on key benefits (including clinician 

and patient reported measures) that demonstrate real-world 

effectiveness of the interventions, as O&P devices are 

unique.  

For example, consider post-amputation recovery, aside 

from differences in patient acuity, a high post-operative 

mortality rate suggests that quality improvement programs 

need to address the prosthetic rehabilitation needs. For 

instance, being mobile and physically active improves 

cardiovascular health, reduces the negative effects of 

diabetes and reduces depression or feelings of isolation.30 

Patient satisfaction and quality of life are associated with 

less time between amputation surgery and delivery of a 

prosthesis.31 Furthermore, satisfaction and quality of life are 

correlated with mobility and patients with no prosthesis are 

unable to be as physically mobile.31 Without prosthetic care 

individuals have increased risk of clinical complications 

including increases in healthcare utilization and spending.17 

Based on the current research, it is reasonable to propose 

that lack of prosthetic rehabilitation negatively influences 

mobility, satisfaction and quality of life. Further investigation 

is needed to establish why wearing a prosthetic device 

improves survival and potentially reduces overall utilization 

or economic burden.32 Without this data, there is an 

underappreciation for the true value of prosthetic 

rehabilitation. 

Standards of care and rehabilitation guidelines post-

amputation 

 The standards of care post-amputation are limited aside 

from the immediate surgical care protocols. Furthermore, of 

the limited guidelines published, there is low physician 

adherence or awareness of the processes.33  HEOR studies 

can inform how a reduction in access to rehabilitation 

services reduces individual health outcomes. The 

integration of health economic studies and evidence into 

clinical practice guidelines adds a dimension that informs 

stakeholders (including patients) on how an intervention 

impacts costs, health outcomes and provides a way to 

evaluate potential consequences of practice. For example, 

there is no standard or regulated time from amputation 

surgery for when a lower limb prosthetic device should be 

provided or intervention initiated, such as a consult with a 

prosthetist.29 However, a recent study analyzed the impact 

of providing a prosthesis earlier, within 0 to 3 months post-

amputation and demonstrated an overall cost savings.23 

Additionally, there is not a standard guideline to what type 

of device is appropriate based on patient presentation.5,33,34 

Future studies should compare selection and design of 

devices and include outcomes such as health utility and 

health-related quality of life. HEOR studies have the 

potential to inform clinical practice guidelines with the 

intention to optimize patient care and outcomes.  

The recently published Mobility Analysis of AmpuTees 

(MAAT II) aims to assist in clinical decision-making by 

presenting standard outcome measures of mobility and 

demonstrates that the presence of comorbidities does not 

preclude an individual from prosthetic mobility success.35 

Specific outcome measures are not standard of practice yet; 

however, the MAAT II study is a start to standardize 

prosthetic decision-making by demonstrating that the 

incorporation of patient outcomes is critical to inform policy.  

The provision and use of a prosthesis is a critical component 

of a person’s rehabilitation after a LLA as it is associated 

with a person’s ability to return to ADLs and reintegrate into 

social or work routines.17,36 The timing from amputation 

surgery to initial device provision has several potential 

influences including the patient’s age, income and 

rehabilitation setting.36 Post-acute care typically occurs at 

home, an in-patient rehabilitation facility or skilled nursing 

facility, all which contribute to varying processes and 

therefore influence timing.36 

Gaps in our knowledge 

In spite of the growing number of potential prosthesis users, 

the increasing number of individuals with functional 

impairment, and of those who experience fall-related 

injuries in the US, research in HEOR among O&P is sparse. 

Nationally, we lack the outcomes research, cost analyses 

and clinical practice guidelines needed to minimize acute 

health complications or emergency utilization, support 

patients’ functional mobility, and reduce costs associated 

with less-than-optimal patient outcomes. Yet, the influence 

of O&P interventions on modifiable clinical outcomes, such 

as functional mobility or pain, are not well understood. There 

is a shortage of empirical outcomes research to 

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demonstrate effectiveness and value of rehabilitation 

services for individuals with LLA.  

Informing Perspective on the Field 

With increasing pressure from payers for clinicians to 

efficiently and effectively provide O&P care, continued RWE 

to demonstrate and describe the value of O&P rehabilitation 

is crucial.17,24 As O&P technology continues to improve and 

provide benefit to all O&P device users, manufacturers 

should work collaboratively with key stakeholders and 

clinical sites to sponsor and disseminate RWE studies. 

Such RWE studies would enhance findings from controlled 

clinical trials that are unable to capture the more broad-lived 

experiences of the naturally heterogeneous, diverse 

population of individuals with different O&P rehabilitation 

needs.  

RWE studies should include elements that focus on the 

enabling factors and perceived needs to further inform on 

how devices are accessed, utilized, and the subsequent 

associated outcomes in diverse populations. RWE is a more 

useful tool to engage physicians and patients following 

specific product launches.13 Publishing observational 

studies of real-world data offers an important opportunity for 

researchers to provide stakeholders with data that reflects 

effectiveness in addition to existing evidence on efficacy 

and safety, particularly related to long-term outcomes. 

These types of studies can also include outcomes, such as 

patient-reported information and economic evidence (e.g. 

cost or utility data), which are growing in demand by payers 

and regulatory agencies.  

CONCLUSION 

It is recommended that future studies consider the 

incorporation of data on additional enabling factors (e.g., 

income and education levels, social networks), perceived 

need factors (e.g., adherence to medication, use of 

prosthesis), and other modifiable risk factors (e.g., 

smoking). Social determinants continue to influence the 

health outcomes of adults who require O&P care. Illness 

that leads to amputation disproportionately affects persons 

with lower socioeconomic status, older patients, and 

persons who are racial/ethnic minorities, which results in 

disproportionately lower mobility and quality of life 

outcomes.37   

As the demands increase in healthcare for value-based 

outcomes and RWE, it is imperative we continue to evaluate 

the impact of O&P rehabilitation services based on 

predisposing factors, enabling factors, and perceived need 

factors together. Determining the value of O&P 

rehabilitation will help patients improve access to 

appropriate, high quality, and beneficial prosthetic 

componentry in a timely manner. If O&P services result in 

cost avoidance, better clinical outcomes, and improved 

quality of life for patients with LLA or after a stroke, then we 

should continue to connect clinicians and researchers to 

inform administrative decision-making, improve coverage of 

services so all patients have equity in access and health 

outcomes.  

CALL TO ACTION 

There is a growing number of prosthesis and orthosis users, 

individuals with functional impairment, and those who 

experience fall-related injuries in the US. Yet, research in 

HEOR among O&P struggles to keep pace. Nationally, 

there is a need for more outcomes research, cost analyses 

and clinical practice guidelines to help minimize acute 

health complications or emergency utilization, support 

patients’ functional mobility, and reduce costs associated 

with less-than-optimal patient outcomes. The influence of 

O&P interventions on modifiable clinical outcomes, such as 

functional mobility or pain, needs a greater level of 

understanding. There is a need for more empirical 

outcomes research to demonstrate the effectiveness and 

value of rehabilitation services for individuals with functional 

impairment who require O&P devices. 

The first call to action recommended is for clinical 

researchers and health outcomes researchers (e.g. 

epidemiologists, economists) to join together to assess 

effectiveness of O&P devices on diverse populations. A 

greater understanding of effectiveness and RWE will 

improve access for patients to appropriate technology. A 

second call to action is for our professional bodies along 

with clinicians, patients and advocates to expand 

awareness of outcomes research. This includes the 

analysis of administrative databases, clinical databases, 

electronic health records, and more by researchers. 

Funding for this type of research will be critical for our 

outcomes and evidence to keep pace with other areas of 

healthcare in evolving need and value.    

ACKNOWLEDGEMENTS 

None. 

DECLARATION OF CONFLICTING 

INTERESTS 

The authors declare no conflict of interest. 

SOURCES OF SUPPORT 

None. 

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Journal. 2021; Volume 4, Issue 2, No.8. https://doi.org/10.33137/cpoj.v4i2.35959 

ISSN: 2561-987X 
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Miller TA, Wurdeman S, Paul R, Forthofer M. The value of health economics and outcomes research in prosthetics and orthotics. Canadian Prosthetics & Orthotics 
Journal. 2021; Volume 4, Issue 2, No.8. https://doi.org/10.33137/cpoj.v4i2.35959 

ISSN: 2561-987X 
THE VALUE OF HEALTH ECONOMICS AND OUTCOMES RESEARCH  

Miller et al. 2021 CPOJ 

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AUTHORS SCIENTIFIC BIOGRAPHY 

Taavy Miller, PhD, CPO, is a research 

scientist within Hanger’s Department of 

Clinical and Scientific Affairs. Dr. Miller 

has broad experience working as a 

certified orthotist/prosthetist at large 

hospital-based systems and in private 

practice as well as teaching P&O at the 

university level. Dr. Miller holds a 

doctoral degree in Health Services 

Research with an emphasis in health 

economics and epidemiology. Her 

research focuses on health equity, 

reducing disparities and improving access through the assessment 

of health outcomes and effectiveness using administrative, clinical 

and patient reported data. She has published several studies in 

peer-reviewed journals and presented abstracts at national and 

international conferences.  

Shane Wurdeman, PhD, CP, is the 

Director of Clinical Research within 

Hanger’s Department of Clinical and 

Scientific Affairs. He entered the field of 

O&P as a technician before 

transitioning to working as an 

orthotist/prosthetist and finally into his 

role as a principal investigator. Dr. 

Wurdeman holds a BS in physics, an 

MS in prosthetics and orthotics, and a 

PhD in biomechanics. He has co-

authored more than 40 peer-reviewed 

manuscripts, published 3 book chapters, and presented more than 

100 conference abstracts within the field of orthotic and prosthetic 

rehabilitation. He is a fellow with distinction of the American 

Academy of Orthotists and Prosthetists, from whom he was 

recognized in 2020 with their prestigious Academy Research 

Award. He currently serves as the Research Director for the 

American Orthotic and Prosthetic Association and Chair of the 

Center for Orthotic and Prosthetic Learning. He has been 

supported by private grants as well as government grants from the 

National Institutes of Health and Department of Defense. 

Dr. Rajib Paul is an associate 

professor of Biostatistics in the 

Department of Public Health 

Sciences and affiliate faculty of the 

School of Data Science at the 

University of North Carolina 

Charlotte. Dr. Paul has a broad 

spectrum of research interests. His 

areas of expertise include Bayesian 

methods, big data analysis, spatial 

and spatiotemporal statistics, 

stochastic computation (Markov 

Chain Monte Carlo algorithms), and 

the applications of statistics to 

environmental, epidemiological (public and community health), and 

health policy-related problems. After graduating from the Ohio 

State University with a Ph.D. degree in Statistics, he joined Western 

Michigan University (WMU) as a faculty in the Department of 

Statistics. He was an Associate Director and one of the founding 

members of the Health Data Research Analysis and Mapping 

(HDReAM) Center at the WMU. He has research experience in 

health disparities, environmental health, population health, and 

social and infectious disease epidemiology. His research focuses 

on identifying socioeconomic and geographic disparities in health 

outcomes and health service utilization. Dr. Paul worked on 

research projects funded by the National Science Foundation, 

Robert Wood Johnson Foundation, the Centers for Disease Control 

and Prevention, DHHS Health Resources and Services 

Administration (HRSA), and Blue Cross and Blue Shield of 

Michigan. 

Dr. Melinda Forthofer is a 

Professor in the Department of 

Public Health Sciences in the 

College of Health and Human 

Services at the University of North 

Carolina Charlotte. From 2016-

2020, Dr. Forthofer served as 

Department Chair, leading the 

department through period of 

exponential growth through the 

addition of new programs and 

concentrations and recruitment of 

new faculty. Prior to joining UNC 

Charlotte, Dr. Forthofer was on the 

faculty at the University of South Florida (1996-2006) and at the 

University of South Carolina (2006-2016). For over 20 years, her 

work has focused on social factors related to health behavior 

change in diverse community settings, often via community-based 

research. Much of her current research is focused on the role of 

social factors in the promotion of health behaviors, particularly the 

role of social networks in physical activity. Her research has been 

supported by over $29 million in extramurally funded research 

grants, via awards from several federal agencies (CDC, HRSA, 

NIH), state health departments, local and national nonprofit 

organizations, and several private sector organizations. 

 

https://doi.org/10.33137/cpoj.v4i2.35959

