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Outcomes Forum: Facing the Future of Orthotics and Prosthetics Proactively: Theory and Practice of Outcomes Measures as a Method for Determining Quality of Services

Adrian A. Polliack, PhD, MIPEM
Stefan Moser, CPO, CPed

ABSRACT

With today's rapid healthcare reforms, the O&P practitioner's ability to quantify the quality of healthcare delivery and treatment cost-effectiveness is seminal to the future success of clinical practice. The evolution of total quality management in the manufacturing sector created concepts of quality control procedures. Today, government, managed care and other industries are assessing and using outcomes measures as the principal mode of quality evaluation of healthcare delivery.

The future of successful patient management will require routine documentation and quantification of patient information, which can be accomplished with the help of existing low-end to high-end technology. The reasons why practitioners should use outcomes measures and how they can be applied to all aspects of clinical practice are discussed and illustrated.

The O&P practice can benefit from objective documentation, data collection and outcomes measures if these tasks are performed in a routine and uniform manner; these practices can improve patient evaluation and measurement, aid in selecting the most appropriate appliances, help negotiate provider contracts, reinforce ethical practice management and minimize the risk of litigation.

Keywords: Outcomes Measures; Patient Management; Prosthetics; Orthotics; Pedorthics.

Introduction

Evolution of Total Quality Management

In 1929, Dr. Walter Shewart of Bell Telephone Laboratories developed a theory of statistical quality control (1). Upon this foundation, Dr. W. Edwards Deming, also a U.S. economist, was invited to Japan in 1950 to deliver a series of lectures on the science of statistical quality, or statistical process control (SPC), which he, together with Drs. Shewart and Joseph Juran, had promoted in the United States in the early 1940s through the American Society for Quality Control (2-4).

SPC is a philosophy stating that the production of goods comprises a series of processes and that it is possible to detect and eliminate negative variables, at any stage, that affect the overall manufacturing process (5). While their work was not accepted in the United States at that time, the Japanese manufacturing sector embraced it, and SPC evolved as a significant component of what is commonly referred to as "total quality management" (TQM).

The Japanese manufacturing sector's adoption of SPC and Deming's 14 points of TQM resulted in a significant improvement in the manufacturing process, effecting a sizable contribution to Japan's ongoing economic success (4). As a consequence, U.S. industry and those of other industrialized nations belatedly adopted SPC philosophy to assess the production of goods. The overall result has meant the foundation of a new culture-one that has directly improved the productivity, quality and competitive position of industry as well as indirectly improved the way we work and live.

Applications to Healthcare:
Evolution of Outcomes Measures

Today, industry and institutions (both government and private) and many other sectors rely on SPC/TQM in their manufacturing processes. SPC/TQM eventually received attention from the healthcare field, arguably the one sector where adopting such measures is most difficult due to its constituency being people and not, for example, machinery. The availability of health-related interventions today exceeds by a considerable margin our societal ability to afford them. Current resource-allocation decisions, while contentious and perhaps inadequate in establishing priorities (6), are guided by considerations of cost in relation to expected benefits, i.e., cost-effective analyses that are likely to yield the most benefit to the population (7-10).

Furthermore, the concept of insurance including managed-care organizations (MCOs) and third-party payers has been widely applied and adopted as a social instrument to more evenly distribute the burden of payments for consumers over time. In turn, MCOs and third-party payers now determine the number, type and priority of services purchased. To this end, between 1965 and 1995 the share of the U.S. gross domestic product devoted to healthcare grew from 5 percent to 15 percent; more than $1 trillion was spent in 1995 alone (7). Federal entitlements such as Medicare and Medicaid also increased exponentially in expenditure. Weinstein and Stason, as early as 1977, gave evidence to this potential problem (10). Other compounding issues affecting the delivery of optimal healthcare include a lack of evidence of the efficacy of medical care treatments; consumers' (patients') growing demand for accessible, affordable and quality healthcare; a wide variation in treatment paradigms; and the inability to compare treatment methods quantitatively.

Over recent years, federal funding for outcomes measures studies has significantly increased. Much of this has been channeled through the U.S. Public Health Service's Agency for Health Care Policy and Research (AHCPR) to examine techniques and methodologies for assessing healthcare service quality, cost-effectiveness, optimal care and priorities of benefits (11). What has become the preferred method of choice is "outcomes measures," a loosely used buzzword that has come to mean different things to different people. One definition has described outcomes measures as the net changes in health status resulting from the delivery of care (12) while another has described it as the assessment of the quality of healthcare and its cost-effectiveness, i.e., the benefit received in relation to the costs incurred (13). Outcomes measures now are being extensively discussed in all fields of healthcare. In the O&P field, there have been publications on the meaning, purpose and potential utilization of outcomes measures in the clinical setting (14-22).

Purpose

The purpose of this article is to review the importance of objective documentation and quantification of information in evaluating patients, the use of outcomes measures, the reasons why practitioners should use these measures, and methods for applying them in clinical practice. The authors will discuss their experiences in using low-cost technology to assist in clinical evaluation. Additionally, the authors will illustrate how outcomes measures can be used to assess patient satisfaction and discuss other promising options in conducting outcomes measures.

Protocols

The O&P practitioner can implement outcomes measures to address a number of aspects specific to clinical practice and patient care, namely, 1) clinical/ biomechanical evaluation, 2) functional health status or quality of life, 3) patient satisfaction, and 4) resource utilization. When assessed collectively, the answers to the following questions can be used to measure outcomes:

• Was the practitioner able to quantitatively obtain data in the evaluation of the patient?
• Did the appliance fit well?
• Did the treatment reduce and/or eliminate symptoms?
• Was the patient able to resume his or her desired activities?
• Did it improve his or her psychosocial well-being?
• Was he or she satisfied with the service rendered?
• Did he or she find the service cost-effective?
• Was there a need to redo the orthosis or prosthesis at any stage of the process?

The implementation and generation of outcomes measures can be assisted with the available technology currently being used for clinical evaluation and assessment. The foremost criteria for use of any technology should be its generation of accurate and meaningful data, ease of operation, and short duration of process. An increasing number of practitioners use CAD/CAM techniques, infrared or video gait analysis systems, or other forms of technology to assist in objective data capturing.

The benefits of using high-end technology in the evaluation process are that it facilitates objective data collection and provides comparisons with subsequent measurements. Alternatively, this article will illustrate ways in which practitioners can implement low-cost technology to facilitate patient evaluation and data collection. The authors' experiences with some of these technologies include the most common instruments: the photocopy machine and the camera.

The OrthoCopy

The authors have devised the OrthoCopy: a modified photocopier that requires an internal metal frame upon which a ½-inch security glass plate is mounted and then is able to withstand loads of up to 285 lbs (see Figure 1) . By adjusting the lens and using two trays, static captures of plantar foot pressures are achieved. The OrthoCopy is able to distinguish among pes planus, a normal medial arch or unusual plantar pressures in an improved graphical form that may not be captured by a Harris mat impression (see Figure 2a , Figure 2b and Figure 3 ). Static captures are copied onto 11- 2 17-inch paper (actual size) and letter size transparencies (reduced 16 percent or 22 percent). The transparencies then are illustrated and discussed with the patient on an X-ray illuminator. The practitioner can use the transparency to indicate the last of the foot, assist in identifying appropriate footwear, show areas of high pressure that need to be unloaded, and articulate orthotic/prosthetic solutions to address specific disorders and symptoms. Transparencies, along with a treatment report, are sent to the prescribing physician and other members of the clinical team. The original paper copy is kept in the patient's chart and can be used for comparative purposes in follow-up visits.

Photography

The authors routinely use photography (e.g., 35-mm color prints, color slides and Polaroid) to document foot and ankle disorders such as calluses, corns, fungus, dermatitis, ulcerations, deformity, amputation, etc. These records all are dated and can be compared on subsequent patient visits (i.e., recording ulcer size over the course of service rendered) (see Figure 4) . Reprints are sent to the prescribing physician and members of the clinical team. A set of prints is kept in the patient's chart. All slides and negative film are filed for educational purposes or for reprint requirements such as when submitting information for an insurance claim.

The Patient Satisfaction Survey

Since January 1994, the authors have routinely collected outcomes measures of patients' satisfaction of their experience of service rendered. A patient satisfaction survey (PSS), a one-page, 10-question English/Spanish form is sent to each patient six months after providing service (see Figure 5) . The rationale for the time lag is it allows the patient to assess satisfaction more objectively and critically. The fact that the survey is sent to patients seen within a three-month period ensures a sufficiently large sample size (n) and allows for statistical, parametric analysis if desired. On this basis, four outcomes measures assessments in a one-year period can be performed. As an example, Table A includes outcomes measures from patients who were sent PSS surveys on July 13, 1995, who received treatment at the facility between Jan. 1, 1995, and March 31, 1995.

The PSS is formatted with a gradient slide of answers in a nominal form, e.g., very well to not at all. The authors, in turn, assign an ordinal value to each answer, e.g., very well equals 1, somewhat well equals 2, somewhat not equals 3, and not at all equals 4. This assignment allows for the use of standard statistical analysis to ascertain the mean satisfaction value for each question asked and, where applicable, the respective two-tailed standard deviation (SD). In turn, each mean value and SD can be interpreted in percentile terms of the best response (see Figure 4) .

After computing the information, the authors compare the data with previous computation periods. This is best presented on a flowchart, cross-comparing each survey period with the other (see Figure 6) . Most results seen in Figure 6 , Figure 6b , Figure 6c , Figure 6d , Figure 6e , Figure 6f , Figure 6g , Figure 6h , and Figure 6i illustrate consistent satisfaction levels. Figure 6f illustrates a decline in satisfaction in the most recent survey period assessed. To this end, the authors became more sensitive to this aspect of patient satisfaction and will implement alternative clinical protocols if this decline does not improve when the next survey period is assessed.

Other Methods of Generating Outcomes Measures Data

Many other modes of conducting outcomes measures can be used to assess cost-effectiveness. Each mode should be developed to benefit individual facilities to the maximum. Some examples include performing outcomes measures on the number of follow-up visits, tracking the number of "redos" of foot orthoses, due to patient dissatisfaction, or assessing patient quality of life improvement on a 0-10 scale. It is important to implement scales that are validated instruments, such as the SF 36 form. Until Medicare and insurance companies mandate specific outcomes measures, it is the practitioner's responsibility to initiate, define and implement the specific outcomes measures most appropriate to his or her practice.

Discussion

In implementing and generating outcomes measures, it is of foremost importance to ascertain the needs of each facility. A self-sustaining motivation for the generation of outcomes measures should be founded on a desire to obtain information on specific questions to which the facility is not privy. For example, if there is a need to document the number of redo's of custom-made foot orthoses each practitioner in the facility makes, then collecting and evaluating such data will allow a sequence of outcomes to be compared over time. The facility may wish to perform outcomes every month or every six months depending on patient volume or patient management concerns, for example.

Moreover, use of existing technology (from low-end to high-end) can aid in generating outcomes measures. Even if low-end technology does not provide numerical quantification (see Figure 1 , Figure 2a , Figure 2b , & Figure 3 ), it can be of significant use in patient education, cross-comparisons with subsequent measures and visual substantiation of treatment modalities. In some cases, it is possible to quantify data numerically from a visual or nominal piece of information. For example, the plantar ulcer area (see Figure 4) can be determined by incorporating a ruler; this can be cross-compared with later photographs to assess ulcer size changes. Such simple measures can become valuable when conducting outcomes measures, validating medical necessity or limiting liability.

Table A and the corresponding flowcharts (see Figure 6) exhibit a highly useful manner in which outcomes measures can be implemented. Most charts indicate a consistent and desirable level of satisfaction. Figure 6f , for example, illustrates a recent decrease in the satisfaction level of patients with reference to the level of practitioner input and explanation and use of the appliance. Without using the PSS to generate this outcome, the facility would not have detected this information. While this may be a one-time negative outcome, as a consequence the practitioners have become more sensitive to this clinical aspect and look forward to maintaining previous levels of satisfaction. If a decline in satisfaction is not reversed by the subsequent survey period (i.e., a low level of satisfaction has been maintained for two sequential outcomes measures), the facility will attempt to implement procedures or protocols to address this particular aspect of patient dissatisfaction. Likewise, with all other aspects of clinical care where outcomes measures are implemented, the same policies should apply.

In regard to the SPC and the use of the outcomes measures, no boundaries or minimum criteria have been established. Inevitably, this may well be set forth in the future by managed care, Medicare and Medicaid, the American Board for Certification in Orthotics and Prosthetics Inc., or each individual facility. In fact, the determination of what minimal response constitutes a baseline and the respective acceptables boundaries (i.e., the standard deviation) is a contentious issue that will no doubt be debated in the future.

Conclusion

Outcomes measures can provide an objective gauge of service delivery; to date, they can serve as the most effective manner in which to conduct quality measurement and analysis of all aspects of O&P patient management. If performed in a routine and uniform manner, outcomes measures can 1) improve clinical evaluation and measurement, 2) assist the practitioner in selecting the most appropriate appliances, 3) assist the facility in negotiating provider contracts, 4) reinforce ethical management, 5) provide improved marketing strategies with more objective and descriptive data, and 6) minimize the risk of litigation.

The O&P field can take advantage of outcomes measures to evaluate all phases of patient management. These include the clinical and biomechanical evaluation phase, quality of life change following the rendering of service, patient satisfaction of the complete facility experience including office follow-up visits, and resource utilization which could include assessing both componentry/material expenditure and the number of follow-up visits, for example. The outcomes measures for each of these listed phases can offer a scale from best (e.g., most cost-effective) and can be consistently and functionally compared with subsequent analyses. Such results can form a basis for patients and third-party payers to assess the healthcare delivery of providers.

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