Disability and Rehabilitation: Assistive Technology

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mobilityRERC state of the science: how science influences public policy in seating and mobility Rita S. Hostak, Doran Edwards & Stephen Sprigle To cite this article: Rita S. Hostak, Doran Edwards & Stephen Sprigle (2013) mobilityRERC state of the science: how science influences public policy in seating and mobility, Disability and Rehabilitation: Assistive Technology, 8:6, 447-453 To link to this article: http://dx.doi.org/10.3109/17483107.2013.823575

Published online: 11 Nov 2013.

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http://informahealthcare.com/idt ISSN 1748-3107 print/ISSN 1748-3115 online Disabil Rehabil Assist Technol, 2013; 8(6): 447–453 ! 2013 Informa UK Ltd. DOI: 10.3109/17483107.2013.823575


mobilityRERC state of the science: how science influences public policy in seating and mobility Rita S. Hostak1, Doran Edwards2, and Stephen Sprigle3 Sunrise Medical, Longmont, USA, 2Advanced Healthcare Consulting, LLC, Franklin, USA, and 3Georgia Institute of Technology, Atlanta, GA, USA



In the United States (US), wheeled mobility and seating equipment is classified as Durable Medical Equipment (DME). DME includes a wide array of devices including canes, walkers, home oxygen equipment, hospital beds, and wheelchairs. Seating and mobility devices reflect a wide range of DME, from relatively simple standard manual wheelchairs and cushions to highly complex manual and power wheelchairs and custom seating systems. This wide range of complexity results in a wide range of policies that govern the provision of seating and mobility equipment. This article results from a presentation during the Wheeled Mobility Rehabilitation Engineering Research Center’s (RERC’s) State of the Science Conference in 2012. The presentation was designed to proffer key concepts related to coverage policies and policy decision-making. Topics covered include an introduction to key policy issues impacting seating and mobility equipment, a description of the barriers that prevent or hinder research being used to inform coverage policy decisions, discussion of the challenges surrounding evidence-based policy decisions regarding seating and mobility, and suggestions of strategies for including policy makers and other stakeholders in setting research priorities and in reporting research findings.

Insurance coverage, medicare, public policy, wheelchair, wheelchair seating History Received 14 June 2013 Accepted 6 July 2013 Published online 8 November 2013

ä Implications for Rehabilitation   

In the United States, wheeled mobility and seating equipment are classified as Durable Medical Equipments which are governed by a wide range of policies. Researchers should be encouraged to supplement research articles with articles that explicitly address clinical and policy implications of the work. Policy-makers should be encouraged to engage researchers to insure the breadth of knowledge and evidence is represented and understood.

In the United States (US), wheeled mobility and seating equipment is classified as Durable Medical Equipment (DME). DME includes a wide array of devices including canes, walkers, home oxygen equipment, hospital beds, and wheelchairs. By Medicare’s definition, DME must meet four criteria: ‘‘can withstand repeated use, is primarily and customarily used to serve a medical purpose, generally not useful to a person in the absence of an illness or injury, and is appropriate for use in the home.’’ This definition, taken from Section 1861 of the Social Security Act, forms the basis for a plethora of policies that govern the provision and coverage of DME [1]. Seating and mobility devices similarly reflect a breadth of DME, ranging from relatively simple standard manual wheelchairs and cushions to highly complex manual and power wheelchairs and custom seating systems. This wide range of complexity results in a wide range of policies that are, justifiably, Address for correspondence: Rita S. Hostak, Vice President of Government Relations, Sunrise Medical, Longmont, USA. Tel: 704 846 4096. E-mail: [email protected]

considered confusing. In some cases, the policies have not kept up with the dramatic changes in technology and the language may be vague and not easily assigned to today’s devices. Many clinicians question the scientific rationale of policies that appear to conflict with their clinical experience. In fact, science and research can and do have an important influence on policy but this influence on the policy-making process often requires different kinds of information and different means to communicate it. This article results from a presentation during the Wheeled Mobility Rehabilitation Engineering Research Center’s (RERC’s) State of the Science Conference in 2012. The presentation was designed to proffer key concepts related to coverage policies and policy decision-making, and specifically, described the means by which policy-makers assess, interpret and apply research results. A group discussion followed this presentation and a synopsis of this discussion follows this article. The presentation and discussion focused on US healthcare policy so may not be applicable to other healthcare systems. An attempt will be made to describe the seating and mobility equipment in a manner that is understandable for readers who are unfamiliar with the US system.

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R. S. Hostak et al.

Specifically, this article will: Introduce the key policy issues impacting seating and mobility equipment  Describe and discuss barriers that prevent or hinder research being used to inform coverage policy decisions,  Introduce the challenges surrounding evidence-based policy decisions regarding seating and mobility,  Suggest strategies for including policy-makers and other stakeholders in setting research priorities and in reporting research findings In the United States, a variety of companies, agencies and organizations develop policies that affect seating and mobility equipment. Collectively, these will be referred to as ‘‘policymakers’’ within this article. The Centers for Medicare and Medicaid Services (CMS) is a key Medicare policy-maker which works closely with four regional DME Medicare Administrative Contractor (DME MACS). Medicaid policy is overseen by CMS as well as State Medicaid agencies. Of course, insurance companies make their own policies but typically review Medicare and Medicaid policies while defining their own. In addition to these ‘‘policy-makers’’, other groups and organizations have direct influence on policies. These include professional organizations such as those for physical and occupational therapists and policy and policy research organizations that assess and evaluate seating and mobility-related policy.

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Key policy decisions To understand the connection between scientific evidence, policy development, and access to technology, it is important to understand the essential policy decisions that must be made before technology can be accepted and covered for provision to patients and billed to third party payers. The best way to describe the regulatory strategy is to use the three- legged stool analogy; coding, coverage and payment. All seating and mobility equipment is categorized using level II Healthcare Common Procedure Coding System (HCPCS) as defined by the Centers for Medicare and Medicaid Services which is part of the US Department of Health and Human Services. Subsequent to coding, the other policy decisions are made. In order for technology to be accessible, there must be assenting decisions for all three legs. As a result, there are three key policy decisions that must be established in order for clinicians, physicians and suppliers to know 1) whether an item is covered, 2) under what conditions it is covered and then 3) what is the reimbursement for the item. If the patient qualifies for a covered item, the supplier reviews the reimbursement decision to decide if reimbursement is sufficient to allow provision of the item. While this article will focus on coding and coverage decisions, payment is an extension of coding and is influenced by evidence that a product or category of products provide a superior clinical outcome relative to the cost differential. So, in effect, pricing is influenced by science and research too. Being able to discern the right regulatory strategy can be very challenging for manufacturers and innovators. Evidence to support the outcome the manufacturer is claiming their product can provide is necessary. Gathering adequate evidence in the current funding environment can be a difficult challenge. Whether a new technology is conceived in a garage to meet the needs of a loved one, at a university funded by grant dollars, or by an existing manufacturer with R&D dollars, scientific evidence and data must be gathered if the technology is going to be available to the people it is designed to serve. The presence of an appropriate HCPCS code to facilitate billing to funding sources is important to long-term access to technology. However, it is not always necessary or even advisable

Disabil Rehabil Assist Technol, 2013; 8(6): 447–453

to seek a unique HCPCS code for a new technology as the first step in the overall strategy. The fact is that the thresholds and requirements for obtaining a unique HCPCS code for a new technology require that the item is already being sold and billed to funding sources. In order for a new technology to be assigned to a new unique HCPCS code, the item must have a significantly different function, operate differently or have a ‘‘significant therapeutic distinction compared to existing, coded treatments or products’’ [2]. If an item is stated to have a therapeutic distinction, comparisons to existing technology must include scientific evidence to support claims. The CMS HCPCS Workgroup considers each coding request and recommends whether a change to the national permanent codes is warranted. Changes include addition of new codes, revision of existing code language or deletion of existing codes. Recommendations for revisions to a HCPCS’ code language are reviewed at regularly scheduled meetings of the CMS HCPCS Workgroup [3]. CMS makes final HCPCS coding decisions.

Barriers that hinder research informing policy Intuitively, one should expect policy-makers to review research findings while discussing policy decisions. We believe that many policy-makers do attempt to apply research findings but several barriers hinder efficient use of existing knowledge. These can include the disconnect between how policy categorizes equipment and the functional performance of equipment, the challenges of researching small user groups and the realities of having multiple policy-makers addressing the same coverage issues. The means by which products are grouped within coding can hinder the ability to study the therapeutic distinction of a technology. Code descriptors are often generic resulting in heterogeneous products or products designed to meet different clinical needs being grouped into a single code. This grouping may add significant complexity and difficulty to designing research studies to inform policy. This scenario particularly challenges comparative effectiveness studies if similarly-coded equipment is to be compared. For example, ultra-lightweight manual wheelchairs, coded as K0005, must weigh less than 30 lbs, have an adjustable rear axle position and be offered with a Lifetime Warranty on side frames and crossbraces. The coding definition is silent on many features exhibited by this class of wheelchair such as seat sizing, backrest height, seat angle, backrest angle, footrest angle as well as the magnitude of the rear axle adjustment. This heterogeneity complicates comparisons between K0005 chairs to wheelchairs within different codes. Anyone interested in comparing K0005 to other wheelchairs would be handcuffed by the heterogeneity within the code since the results would almost certainly be reflective of the specific products used rather than the breadth of chairs within this one code. Moreover, the results would offer little benefit to policy-makers if the conclusions applied only to a subset of products in a single code. In research language, the external validity of studies into product coding is hindered by the diversity of the equipment within codes. It is important to note that the presence or absence of a unique HCPCS code does not by itself ensure or deny access. Because HCPCS coding is a separate policy issue from coverage policy, having a unique HCPCS code does not guarantee that any payer will cover it. Furthermore, if this unique HCPCS code targets a small user group, coverage can be hard to obtain due to lack of research evidence. A case example is available in the category of wheeled mobility. In 2009, CMS implemented code E2295Manual Wheelchair Accessory, for pediatric size wheelchair, dynamic seating frame, allows coordinated movement of multiple positioning features. Even before this unique code was

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How science influences public policy in seating and mobility?

implemented, several State Medicaid programs and private insurers covered dynamic seating frames when adequate documentation of the medical need was provided. However, once a unique HCPCS code was implemented and awareness of the technology increased, it became more important for payers to establish a coverage policy. Some payers have a preestablished requirement in which they only cover new technology when scientific evidence exists to demonstrate the therapeutic distinction and outcome. The studies attempting to demonstrate the benefits of dynamic seating have involved small sample sizes, due, in large part, to the small pediatric population that benefit from dynamic seating. Additionally, observational outcomes were not accepted as sufficient evidence to support coverage, rather more objective measurements have been requested. Consequently, dynamic seating has not been covered by those payers that demand highly controlled studies. Decisions about coverage of a technology clearly impacts how accessible that technology is to those who have a medical need for it. Another distinction between coding and coverage is important to address. Coding decisions are made by a single entity; coverage is made by each funding agency. For many reasons, policy-makers have struggled to find meaningful and defensible methods for determining whether a technology should be covered and what the conditions for coverage should be. While some insurers/payers develop their own policies, many find it easier and more cost effective to adopt the Medicare policy. The strategy of adopting the coverage policies of Medicare has certain advantages (i.e. knowledgeable staff dedicated to reviewing scientific evidence, established processes for considering coverage requests, and opportunities for public involvement). There are important disadvantages as well. In some instances, the population of people served can be quite different and/or legal mandates for various programs are different as well, such as Medicare versus Medicaid.

Challenges surrounding evidence-based policy In an attempt to develop meaningful and appropriate coverage policies, there is a growing trend toward the application of evidence-based policy development. If evidence-based practice informs better treatment decisions, should not one be able to assume the same should hold true for applying the scientific evidence to policy? Evidence-based practice has been described as the ‘‘integration of best research evidence with our clinical expertise and our patient’s unique values and circumstances’’ [4]. This definition makes it clear that research evidence does not, or at least should not, stand alone. Indeed, the best opportunity for achieving the desired outcome occurs when all relevant information is considered, and that includes clinical expertise. Unfortunately, current efforts to use evidence-based approaches to inform policy decisions related to the use of technology often rely solely on research evidence and devalue clinical expertise and often even ignore important details about the patient’s unique values or circumstances. This method of evidence-based policy development has resulted in coverage policies for wheeled mobility and seating that limit access for people with disabilities and prevent patients from obtaining technology that their medical team has determined will assist in achieving important outcomes. Washington State Department of Social and Health Services serves as an example of applying an evidence-based hierarchy to develop coverage policy. A review of letters denying coverage for prescribed wheelchair cushions indicate that some skin protection cushions are not covered if the individual does not have an existing pressure ulcer and, in some cases, does not have a severe


pressure ulcer. Specifically, one letter states: ‘‘The Department has denied a Jay ION cushion because evidence submitted stated you had no skin breakdown and therefore do not meet the criteria for this level of cushion’’ (letter, March 27, 2012) and another stated: ‘‘Even with a Stage II wound, he does not qualify for a roho (sic) cushion. (letter, April 27, 2011). Denial notices further reference WAC 182-501-0165 as the basis for these decisions. This administrative code essentially defines the hierarchy of evidence and how it is applied to make coverage decisions (Table 1) [5]. Multiple studies into pressure ulcer risk factors have found the existence of a previous ulcer to be a predictor of pressure ulcer development [6–10]. From a clinical point of view, clinicians would undoubtedly agree that pressure ulcer prevention is the desired medical outcome. Clinicians who specialize in wheeled mobility and seating assess persons at risk of developing pressure ulcers to determine the most appropriate equipment. Clinicians are trained to assess an individual’s specific risk factors based upon injury, underlying medical diagnoses, sensation status, posture, weight shift ability, heat, moisture, etc. Coupling the results of this assessment with knowledge about seating and positioning equipment should result in a prescription based upon the science of risk factors and the individualistic factors of the client. The use of this combination of information is consistent with the philosophy of evidence-based practice but differs from the use of hierarchical assessments of evidence. Research on seat cushions, and specifically their pressure ulcer prevention, is limited. With respect to randomized control trials, one study gave cushions and new wheelchairs to elders living in institutions [11] and another study on elders in institutions randomly assigned a cushions [12]. Both demonstrated effectiveness of skin protection cushions. Policy-makers are called upon to decide how these studies generalize to both elder and non-elder beneficiaries living in the community. Longstanding observational studies exist on persons living in the community [13–15]. They conclude that wheelchair cushions are effective in preventing pressure ulcers and should be chosen after assessing individual needs. However, these types of studies do not carry the weight of controlled trials. This example raises a philosophical conflict with both sides holding rational opinions. There exists a lack of research evidence on the ability of adjustable skin protection wheelchair cushions to prevent pressure ulcers. Using Washington State’s hierarchy, this lack of evidence can form the basis for the policy that limits these cushions to a treatment rather than preventative option. The opposing side would argue that evidence suggests prevention is very important and clinicians should be empowered to collect individualistic factors before deciding on the cushion that best meets their client’s needs. Moreover, since the policy appears to acknowledge that adjustable skin protection cushions are useful for pressure ulcer treatment, clinicians should have this option for persons at high risk for preventative purposes as well. So, why is there such a void of high-level scientific evidence in the area of wheeled mobility and seating? Why is not there more strong scientific literature and well-designed clinical trials such as Type I evidence (Meta-analysis done with multiple, well-designed controlled studies) or multiple Type II evidence (well-designed experimental studies) regarding wheeled mobility and seating with consistent results? There are several key factors that prevent the development of rigorous studies of wheeled mobility and seating technologies. One major barrier lies in the heterogeneity of wheelchair users with respect to medical diagnoses. Another barrier is the relatively small size of the population and its various subsets such as power versus manual wheelchair users and full time versus part time users. Further dividing up these categories by the


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Table 1. Washington state WAC 182-501-0165 [5].

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The department uses the following processes to determine whether a requested service described in subsection (1) is medically necessary: (a) Hierarchy of evidence – How defined. The department uses a hierarchy of evidence to determine the weight given to available data. The weight of medical evidence depends on objective indicators of its validity and reliability including the nature and source of the evidence, the empirical characteristics of the studies or trials upon which the evidence is based, and the consistency of the outcome with comparable studies. The hierarchy (in descending order with Type I given the greatest weight) is: (i) Type I: Meta-analysis done with multiple, well-designed controlled studies; (ii) Type II: One or more well-designed experimental studies; (iii) Type III: Well-designed, quasi-experimental studies such as non-randomized controlled, single group pre-post, cohort, time series, or matched case-controlled studies; (iv) Type IV: Well-designed, non-experimental studies, such as comparative and correlation descriptive, and case studies (uncontrolled); and (v) Type V: Credible evidence submitted by the provider. (b) Hierarchy of evidence – How classified. Based on the quality of available evidence, the department determines if the requested service is effective and safe for the client by classifying it as an ‘‘A,’’ ‘‘B,’’ ‘‘C,’’ or ‘‘D’’ level of evidence: (i) ‘‘A’’ level evidence: Shows the requested service or equipment is a proven benefit to the client’s condition by strong scientific literature and well-designed clinical trials such as Type I evidence or multiple Type II evidence or combinations of Type II, III or IV evidence with consistent results (An ‘‘A’’ rating cannot be based on Type III or Type IV evidence alone). (ii) ‘‘B’’ level evidence: Shows the requested service or equipment has some proven benefit supported by: (A) Multiple Type II or III evidence or combinations of Type II, III or IV evidence with generally consistent findings of effectiveness and safety (A ‘‘B’’ rating cannot be based on Type IV evidence alone); or (B) Singular Type II, III, or IV evidence in combination with department-recognized: (I) Clinical guidelines; or (II) Treatment pathways; or (III) Other guidelines that use the hierarchy of evidence in establishing the rationale for existing standards. (iii) ‘‘C’’ level evidence: Shows only weak and inconclusive evidence regarding safety and/or efficacy such as: (A) Type II, III, or IV evidence with inconsistent findings; or (B) Only Type V evidence is available. (iv) ‘‘D’’ level evidence: Is not supported by any evidence regarding its safety and efficacy, for example that which is considered investigational or experimental.

levels of equipment being used (i.e. standard versus complex rehab equipment), and one can readily infer that subpopulations are small. Both the heterogeneity and small size render the results subject to concerns about statistical significance, bias, or insufficient numbers to drive policy for large numbers of covered individuals. In addition, even people with the same diagnosis and using the same equipment will probably have undergone different mobility equipment evaluations, live in different environments, have varying levels of support, have diverse transportation options, serve different societal and familial roles and exhibit many other differences in confounding variables. This is a significant barrier to organize large randomized clinical trials with a large sample and one that controls these variables. It is no accident that the two wheelchair cushion studies using randomized trial methodology used persons residing in long term care facilities. The same factors that challenge researchers in designing strong studies are the same reasons policy-makers give for refusing to allow study results to be generalized to other populations. When policy-makers determine that some types of evidence are more valid than others, viewing types of evidence as a hierarchy rather than a continuum, notably by substituting journals for judgment, there is no guarantee that superior clinical outcomes will be achieved. When funding programs determine coverage guidelines or make individual coverage decisions based exclusively on research evidence, it is no longer consistent with evidence-based medicine or evidence-based practice, as this sort of policy development has selectively excluded important information that should also be used to inform these important decisions. As the trend of applying evidence to policy is expanding, so is the demand for evidence of comparative effectiveness regarding seating and mobility. As an example, consider the two categories of skin protection wheelchair cushions (adjustable & nonadjustable). There are myriad barriers to designing a study to determine comparative effectiveness. One key barrier is the

difference in the respective HCPCS code definitions and testing requirements. The only distinction between products in these codes is the ability to add or remove components (i.e. pads, bladders, air) in the field. This definition was designed to identify cushions that could be individualized to the user by adjusting the cushion. While this is a very important characteristic for patients who are expected to change over the life of the cushion, there are other key technological differences that are not distinguished by the codes. The result of this limited coding language is that within either code, the cushions vary so much that individuals could have very different outcomes depending on the specific cushion they receive. The complexity caused by all the confounding variables (i.e. person differences, usage differences, cushion differences) makes comparative effectiveness research, at the least, difficult, costly and unlikely to produce meaningful or useful conclusions. This is why it is important to view evidence as a continuum rather than a hierarchy. For complex rehabilitative wheeled mobility and seating, much of the research is still attempting to describe the populations that benefit from the use, or to determine the relationship between certain technological factors and the outcome. This type of research must occur before studies related to cause and effect can occur and have meaningful, applicable results. Years of research and substantial dollars must be spent to achieve what some view as the highest level of scientific evidence. One could ask whether scientific research is always needed in the case of technology. Unlike pharmaceuticals, in many situations, functional outcomes related to wheeled mobility and seating can easily be observed. However, observational functional outcomes are not typically recognized as level-1 evidence. And, in some situations, it would be unethical to withhold treatment for the sake of research which obviates some controlled comparisons. There is a critical need for policy-makers, payers, researchers, clinicians, consumer groups and industry stakeholders to collaborate on evidence-based policy development. Policy-makers must be involved in setting research priorities. Policy-makers should be

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encouraged to communicate with stakeholders, including researchers, to better understand the state of knowledge. Payers have access to data that should be utilized considered when establishing policy. Researchers have an obligation to consider policy implications when designing research projects and writing reports. It would be extremely useful for journals to include at least one person on their review board that have a strong background in public policy to consider policy implications. HCPCS coding decisions should take into consideration how technology groupings and definitions impact the ability for researchers to effectively compare technologies within the codes. And, all stakeholders need to come together to discuss the application of scientific evidence in informing policy decisions. There is much to be learned by all parties in order to ensure that:  Scientific evidence is applied properly to ensure sound and defensible policies  Research priorities (and funding) includes filling gaps in the evidence  Evidence needed by clinicians and policy-makers in making decisions is available, meaningful and appropriately applied to correct patient populations  Policies developed based on the evidence will impact the quality of care and quality of life for people with disabilities and  Research designs and methodologies are established for DME that provide meaningful information and are affordable, sustainable and achievable. Clearly established research designs and methodologies should consider all the outcome variables associated with wheeled mobility and seating. The use of functional levels rather than medical diagnoses should be acceptable to allow results to be generalized to people with the same functional level even when the diagnoses are different. A research agenda that serves the needs of policy-makers would open opportunities for public and private partnerships that would potentially increase funds available for research. In addition, a well understood regulatory pathway and accepted research designs that are affordable and achievable would provide predictability regarding coverage for new equipment. The resulting innovation and would allow new technology to reach the people for whom it is intended without adding unnecessary costs to the health care system. An increase in research with results and conclusions that can be reasonably applied to well-defined patient populations would go a long way to ensure appropriate policies are developed and ensure technology decisions made by the clinical team are based on outcomes that have a higher level of predictability.

Acknowledgements The authors and mobilityRERC thank RESNA for hosting this State of the Science Conference, and Lauren Bowers and Lisette Vonk for organization and operational support.

Declaration of interest Ms Hostak is employed by Sunrise Medical, a wheelchair manufacturer. Her responsibilities include regular interactions with the Centers for Medicare and Medicaid Services (CMS) and other insurance carriers. Dr. Edwards offers consultation services to CMS and CMS contractors and other insurance carriers. Dr. Sprigle has no declarations to report. The mobilityRERC State of the Science Conference was supported, in part, by the following sponsors: Invacare, Permobil, Pride Mobility, The Roho Group and Sunrise Medical. The mobilityRERC is funded


by the National Institute on Disability and Rehabilitation Research of the U.S. Department of Education under grant number H133E080003. The opinions contained in this article are those of the authors and do not necessarily reflect those of the U.S. Department of Education.

References 1. Social Security Act. 2. Centers for Medicare and Medicaid Services. HCPCS coding decision tree. 2006 October 16, 2006. Available from: http:// www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/ HCPCS_Decision_Tree_and_Definitions.pdf [last accessed 12 Oct 2012]. 3. Center for Medicare and Medicaid Services, Innovators’ Guide To Navigating Medicare, Health and Human Services, Editor; 2012. p. 55. 4. Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: how to practice and teach EBM. 3rd ed. Edinburgh: Churchhill Livingstone; 2005. p. 299. 5. Washington Administrative Code. Medical and dental coverage — fee-for-service (ffs) prior authorization — determination process for payment., 7/1/11. 6. Allman RM, et al. Pressure ulcer risk factors among hospitalized patients with activity limitation. J Am Med Assoc 1995;273:865–70. 7. Bates-Jensen BM, et al. Characteristics of recurrent pressure ulcers in veterans with spinal cord injury. J Spinal Cord Med, 2009;32: 34–42. 8. Garber SL, et al. Pressure ulcer risk in spinal cord injury: predictors of ulcer status over 3 years. Arch Phys Med Rehabil 2000;81: 465–71. 9. Horn SD, et al. The National Pressure Ulcer Long-Term Care Study: pressure ulcer development in long-term care residents. J Am Geriatr Soc 2004;52:359–67. 10. Salzberg CA, et al. A new pressure ulcer risk assessment scale for individuals with spinal cord injury. Am J Phys Med Rehabil 1996; 75:96–104. 11. Brienza D, et al. A randomized clinical trial on preventing pressure ulcers with wheelchair seat cushions. J Am Geriatr Soc 2010;58: 2308–14. 12. Conine TA, et al. Pressure ulcer prophylaxis in elderly patients using polyurethane foam or Jay wheelchair cushions. Int J Rehabil Res 1994;17:123–37. 13. Garber SL, Dyerly LR. Wheelchair cushions for persons with spinal cord injury: an update. Am J Occup Ther 1991;45:550–4. 14. Krouskop TA, et al. The effectiveness of preventive management in reducing the occurrence of pressure sores. J Rehabil R D 1983;20: 74–83. 15. Reswick J, Rogers J. Experience at Rancho Los Amigos Hospital with devices and techniques to prevent pressure sores. In Kenedi R, Cowden J, and Scales J, eds. Bedsore Biomechanics. London: University Park Press; 1976. pp. 301–14.

Appendix 1 The mobilityRERC from the Georgia Institute of Technology held its State of the Science Conference as a part of RESNA’s 2012 Annual Conference. A discussion session was held following the presentation: ‘‘How science influences public policy in seating and mobility’’, by Rita S. Hostak and Dr. Doran Edwards. This synopsis will outline the points of discussion and suggestions for future activity in this area. As a discussion session, one cannot infer that specific comments represented the consensus or even the majority of the attendees. Comments should also be taken as excerpts of a larger context and not considered definitive without reference to the whole context. They are simply presented as a documentation of issues that were discussed. The session began with a brief discussion of the barriers that hinder the use of research within policy decisions focusing on researchers and policy-makers. The remainder of the session covered a range of topics that could be generally grouped into 3 categories: strategizes for enhanced dissemination, research design implications, and opportunities for future initiatives.


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Substantial discussion focused on how to better disseminate research results. The group generally agreed that researchers tend to disseminate to other researchers. Therefore, strategies that better inform clinicians and policy-makers are needed. Of course, researchers are obligated to disseminate within peer review journals which may limit an author’s ability to address policy within a manuscript. As a result, policy-makers may see the research as potentially useful in their decision making but the constraints of publication limit or remove the application of results to the beneficiary population under consideration. Both Dr. Edwards and Ms. Hostak emphasized that any type of publication that is accessible and available has importance. Because information must be in print to be referenced, they engaged the audience in discussion about ways to increase the availability of research to broader audiences. Strategies and suggestions included: Researchers can follow up on the peer review journal with a ‘lay version’ that is distributed in a more mass forum. Many trade or specialty periodicals target rehabilitation professionals and persons with disabilities and are very willing to publish articles by researchers. These articles would be tailored to a lay audience and explicitly address clinical and policy implications of the work. These articles can refer to the peer reviewed article as a source for more in-depth information. Journals can expand the use of break-out boxes designed to include implications of findings. Some Journals such as Disability and Rehabilitation: Assistive Technology have a ‘implications for rehabilitation’ breakout. Authors should be encouraged to include ‘implications for policy’ as a part of this section. One barrier to this approach is that policy is quite specific to a country, and often, to a region within a country. Archival journals that have a worldwide focus might be less interested in entertaining the needs of just one country’s policies. This barrier might be overcome by engaging the Journal’s Editorial Board. Since they represent many countries, members can be asked to relate research findings to policies which impact their respective countries or regions. Journals should seek to include reviewers with an understanding of public policy.

other diagnostic categories, and (2) documenting the impact of seating and mobility devices can suffer due to smaller sample sizes limited to single diagnoses. For example, assessing the functional outcomes of a positioning wheelchair cushion can and should reflect upon the outcomes of persons who need postural support, accommodation and/or correction, regardless of their medical diagnoses. In some cases, statistical significance and power is lessened to the point that policy-makers cannot see the benefit. In other cases, the outcomes reflect measurements that are not readily translatable to the clinical setting. Because wheeled mobility and seating focuses on function, the group spent time discussing how inclusion could be based upon functional measurements.Naturally, the ICF was identified as a viable means to reflect function of subjects and functional outcomes. The ICF has been adopted by nearly 200 countries and has received the support of many professional organizations such as the American Medical Association, American Physical Therapy Association and the American Occupational Association. [1–3] Within wheeled mobility and seating, the ICF would describe people using the constructs of impairment, activity limitation, and participation restriction. Using the example above, recruiting persons to study positioning cushions might, for example, focus on persons who have ‘‘moderate problems with maintaining a seated position’’. This type of inclusion criteria seems to feed directly into the needs of policy-makers making coverage decisions. Rather than trying to list all diagnoses that might involve problems in ‘‘maintaining a seated position’’, coverage would include persons with this functional problem as articulated by the ICF nomenclature. Since most policy-makers try not to become bogged down in exhaustive lists of diagnosis codes, functional designations have the potential to cover the needs without the hassle. The counter argument is that research and healthcare policy exist in a medical model of disability, and therefore, research and policy should reflect that model. Persons making this argument support the idea of using ICF but in combination with traditional descriptors of diagnosis. This approach must acknowledge the risk that subject cohorts may share a functional classification but cross several diagnostic categories. Therefore statistical power to discern differences within a diagnosis can be compromised. From the policy standpoint, the broader groupings assist in applying appropriate technology to a large group of people with similar needs. But from the research standpoint, an increased number of subjects may be needed to improve statistical power or risk missing important findings in subsets of the population. Of course, subject selection is only one of many methodological issues that must be addressed. Some policy-makers have begun to rely on traditional hierarchical levels of evidence to drive policy. While this appears prudent, it does not reflect the fact that certain seating and mobility research questions cannot be performed using certain methodologies. For example, a functional device, such as a manual wheelchair, can never be blinded to the user, and researchers evaluating functional outcomes could also never be blinded to this device. This reality does not mean that all research should be discounted. Rather it requires that wheeled mobility and seating research should proactively seek to minimize bias within their studies. On the other side of the equation, funding agencies and policy-makers should recognize the idiosyncrasies of assistive technology research and should not hide behind a hierarchy of methodologies that does not fit well in the functional domain. Unless all stakeholders work together to agree on valid approaches, a barrier to establishing evidence will remain. Dialogue with potential policy-makers prior to development of protocols may reveal opportunities for inclusion of significant questions that can be answered at the same time as the direct research study.

Research design implications

Opportunities for future initiatives.

Designing a research study involves making many compromises with respect to hypotheses and methods. Researchers must juggle the often competing needs of internal and external validity. Those compromises may result in data that are unusable in the policy arena or not applicable to the ‘‘real world’’ setting of clinical practice. A substantial amount of wheelchair and seating research includes persons from a single diagnostic category. This selection process is often done at the behest of funding agencies and even journals that seek a homogeneous cohort with respect to pathophysiology. At least two problems result from this approach: (1) policy-makers and others seeking to use research results might question the generalizability of results to

One recent publication was cited as an example opportunity. Members of the Alliance of Wound Care Stakeholders used a Delphi technique to develop principles to guide stakeholders involved in wound healing research [4]. The Delphi approach appeared to target researchers and the article is unclear about how many policy-makers were represented. Nonetheless, this article was identified as an important step in acknowledging the challenges and complexities of doing wound care research. The group was encouraged to attempt to do a similar study for wheeled mobility and seating research. The group then discussed the potential of hosting a small conference that can be used to establish consensus on principles to guide persons

Barriers that hinder the use of research by policy-makers By definition, research involves the systematic collection and use of data to create generalizable knowledge. Therefore, one can and should expect research to be usable by policy-makers and, by extension, to impact persons with disabilities. So, why has this not occurred and what steps can be taken to better connect researchers and policy-makers? Discussing the question, What are the obligations of researchers to inform public policy? identified the following barrier. Researchers’ primary obligation is to the funding agency, and, as a result, researchers try to identify projects based upon what they believe funding agencies want rather than considering public policy implications. If the funding agency requires that projects reflect policy, the researcher will respond accordingly. So, this raised a follow-up question: What is the responsibility of funding agencies to inform public policy? Comments were made that funding agencies do not keep up with public policy so their ‘call for proposals’ are outdated or have limited application to policy. In some cases, funding agencies may not even be aware that their questions may have a potential for impact of public policy. Discussions about these possibilities early in the deliberations may provide avenues for collaborative studies with public policy impact.

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Disabil Rehabil Assist Technol, 2013; 8(6): 447–453

Strategies for enhanced dissemination

DOI: 10.3109/17483107.2013.823575

How science influences public policy in seating and mobility?

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doing seating and mobility research. This would include discussions on many of the topics covered in this discussion session including balancing internal and external validity, subject selection, and outcome measures. Inclusion of editors and policy-makers in some of those discussions could be fruitful (1) American Physical Therapy Association. APTA Endorses World Health Organization ICF Model. 2010 [cited 2012 July 24]; Available from: http://www.apta.org/Media/Releases/APTA/2008/ 7/8/.


(2) Rondinelli, R.D., et al., Guides to the Evaluation of Permanent Impairment. 2008: American Medical Association. (3) American Occupational Therapy Association. Research Priorities and Parameters of Practice for Occupational Therapy. 2003 [cited 2012 August 8]; Available from: http://www.aotf.org/resourceswlwlibrary/researchprioritiesandparametersofpractice.aspx. (4) Serena, T., et al., Consensus principles for wound care research obtained using a Delphi process. Wound Repair and Regeneration, 2012. 20: p. 284–293.

mobilityRERC state of the science: How science influences public policy in seating and mobility.

In the United States (US), wheeled mobility and seating equipment is classified as Durable Medical Equipment (DME). DME includes a wide array of devic...
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