Neurologic and Functional Evaluation Outcomes Assessment Tools in Cervical Spine Surgery



Neurologic and Functional Evaluation Outcomes Assessment Tools in Cervical Spine Surgery


Krzysztof B. Siemionow

Isador H. Lieberman



Outcomes research itself can be thought of as refined and enhanced clinical research, with a focus on patient-based outcomes (1). Several factors including rapidly increasing health care costs, variations in practice patterns, utilization of health care services, patient expectations, clinical outcomes for related procedures, and the deficiencies in the research literature have stimulated the rethinking of clinical research methods (1). Outcomes research can be used to justify new medical treatment modalities and health care reimbursements.

When one discusses the measurement of outcomes, there are multiple variables that must be considered. These include biologic and physiologic variables, as well as physician-derived symptom status. These traditional clinical variables, that is, patient symptoms (e.g., neck pain), physical findings (e.g., weakness), and laboratory investigations (e.g., x-ray, nerve conduction studies) are prone to reporting biases. More recently, objective outcome measures have been introduced that take into account the patient’s self-report of their physical function, general health, and overall quality of life—so-called patient-based outcomes (2). These measures may be as important as or even more important than traditional clinical measures because they can reduce or eliminate physician bias and perhaps more directly answer the question, “Is the patient feeling/doing better?” Other measurable variables include work status, patient satisfaction, treatment-related complications, and cost-related variables (3).

One of the more common formats used to gather data to measure patient-based outcomes is questionnaires. These questionnaires should be appropriate with regard to content and that they are understandable to the patients or populations being assessed.

Patient-based outcomes also have limitations as some questionnaires may only be partially completed or completed by someone other than the patient because of cognitive or physical disabilities the patient may have.

Wilson and Cleary have proposed a conceptual model of five types of outcomes to help answer the question: which outcomes does the researcher want to measure (4)? The first two—biologic and physiologic factors and symptoms—of the five types of outcomes are traditional clinical variables found in most clinical studies and consist of data from physical examinations and laboratory investigations. The next three types of outcomes are patient-based measures: function measures, general health perceptions, and overall quality of life. Function measures assess the ability to perform specific tasks covering physical, social, role, and psychological functions. General health perceptions integrate the various aspects of health as reflected in a patient’s subjective rating. The overall quality of life type of outcome is a general measure of a patient’s well-being. The key to Wilson and Cleary’s proposed model is that the various types of outcomes are distinct concepts that may or may not track together as a patient improves. For example, the level of pain (a symptom) may not correlate with radiographic film changes (a biologic factor). As one works through the various types of outcomes in the model, outcomes are increasingly influenced by individual and social factors (4).

In this chapter, we review the traditional and patientderived outcome measurement tools that are helpful when conducting clinical research related to cervical spine surgery.


TRADITIONAL CLINICAL OUTCOME MEASURES IN CERVICAL SPINE RESEARCH

A variety of traditional outcome measures have been reported in studies pertaining to the cervical spine. For example, several grading or classification schemes have been used to report the outcomes of cervical spine surgery in patients with cervical myelopathy secondary to
conditions including rheumatoid arthritis, cervical spondylosis, and ossification of the posterior longitudinal ligament. Although a number of classification systems for myelopathy have been reported, perhaps the most commonly used are the (a) Ranawat classification (5), (b) Nurick classification system (6), (c) Japanese Orthopaedic Association (JOA) score (7), and, more recently, the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) (8). Other myelopathy classifications include the Cooper myelopathy scale (9) and European myelopathy score (10). The Myelopathy Disability Index (MDI) is a patient-based outcome questionnaire that will be discussed in the next section (11).








TABLE 21.1A Ranawat Classification















Class I


No neural deficit


Class II


Subjective weakness with hyperreflexia


Class IIIA


Objective findings of weakness and long tract signs, ambulatory


Class IIIB


Quadriparetic and nonambulatory


The Ranawat classification scale was originally devised to evaluate the neurologic function of patients undergoing cervical spine fusion for rheumatoid involvement of the cervical spine (12). Class I is normal or intact. Patients with subjective weakness with hyperreflexia and paresthesias are class II. When patients develop objective weakness with long tract signs, they are categorized as class III. Class III is further subdivided into IIIA, which is composed of patients who are ambulatory, and IIIB, which is composed of patients who are nonambulatory (Table 21.1A).

In addition to the Ranawat scale, the American Rheumatism Association (ARA) functional grading system developed by Steinbrocker has been used to evaluate the overall functional status of patients with rheumatoid arthritis (Table 21.1B) (13). The ARA functional grading system is not a spine specific instrument but rather used to assess the physical function of patients with rheumatoid arthritis taking into account their overall disease burden from rheumatoid arthritis. Although this scale has been used to report postoperative improvement (14,15), the ARA classification system is so crude that it has largely been dismissed by present-day rheumatologists (11). The problem with the ARA functional grading system and, to a lesser degree, the Ranawat neurologic classification system is that they both lack sensitivity to change—they fail to differentiate quite significant clinical changes between classes II and III, and they are also subject to great interobserver error.








TABLE 21.1B ARA Functional Grades















Grade 1


Complete ability to perform all usual duties without handicaps


Grade 2


Adequate for normal activities despite handicap of discomfort or limited motion of one of the joints


Grade 3


Limited to few or none of the duties of usual occupation or self-care


Grade 4


Incapacitated, largely or wholly bedridden, or confined to a wheelchair with little or no self-care









TABLE 21.2 Nurick Grading Scheme





















Grade 0


Signs and symptoms of root involvement but without evidence of spinal cord disease


Grade 1


Signs of spinal cord disease but no difficulty in walking


Grade 2


Slight difficulty in walking which did not prevent full-time employment


Grade 3


Difficulty in walking which prevented full-time employment or the ability to do all housework but was not so severe as to require someone else’s help to walk


Grade 4


Able to walk only with someone else’s help or with the aid of a frame


Grade 5


Chairbound or bedridden


Nurick originally proposed a grading scheme to measure the degree of walking difficulty in patients with myelopathy secondary to cervical spondylosis (6). The Nurick grading scheme expands the grades from four on the Ranawat classification scheme to six (Table 21.2). It adds two additional grades (grades 3 and 4) to better differentiate the degree of walking dysfunction. These two additional grades create further distinction between grades IIIA and IIIB in the Ranawat scheme. Grade 3 in the Nurick scale describes the individual who cannot work inside or outside the home because of walking difficulty and grade 4 describes a patient requiring some form of assistance to ambulate. This expansion in the Nurick scheme increases its sensitivity while maintaining simplicity and ease of use. This has resulted in the widespread use of this outcome measure by many investigators. Several other classification systems, based on variations of the Nurick grading system, have also been used to measure the degree of walking disability (16, 17 and 18).

The JOA score is probably the most comprehensive of the traditional measures quantifying the degree of impairment secondary to myelopathy. It is objective in nature and measures both upper and lower extremity motor and sensory dysfunction as well as bladder function. A total of 17 points can be scored (Table 21.3) (7,19). Lower scores indicate worse function and higher scores better function. While the JOA score is the most comprehensive, it has several limitations. When comparing its grading of lower extremity function with the Nurick grade, it is less sensitive and less descriptive. The JOA uses five scores instead of six in the Nurick scheme and the three intermediate scores all assume the need for an assist device (Nurick grade 4). One might also argue that the score is perhaps too heavily weighted with respect to sensory dysfunction with 6 out of 17 total points used to measure it. Finally, measurement of upper extremity function, while an excellent principle to include, would require some translation or cross-cultural adaptation for more widespread use across other populations because in the JOA score grading is based on the ability or inability to use chop sticks. The JOA has recently been revised to make it more patient oriented and to make it more scientific from the standpoint of medical statistics (20). The product of this revision is the JOACMEQ, which is currently being validated in a surgical setting (8). In this questionnaire, factor analysis was used to divide the
24 questions into different factorial domains, and the domains were categorized by interpreting the context of the questions that were divided into each domain. The five domains into which the 24 questions were divided were designated as (a) lower extremity function, (b) quality of life, (c) cervical spine function, (d) bladder function, and (e) upper extremity function. Then the equations to calculate the score for each domain were assembled in order to intuitively indicate the status of patients in the five different functional domains. The numbers prefixed to the answers chosen by the patients were multiplied by the coefficients so that the difference between the minimum score representing the worst condition and the maximum score representing the best condition would become 100. The equations were further manipulated by other supplemental coefficients so that the minimum score became 0 and the maximum score became 100 to make recognition of the status of the patient as intuitive as possible. The authors are currently investigating if the changes in the patient’s functional status after surgical treatment would be accurately reflected by the changes in the scores in the different domains.








TABLE 21.3 Criteria of Evaluation of the Operative Results of Patients with Cervical Myelopathy by the Japanese Orthopaedic Association


















































































































I. Upper Extremity Function


II. Lower Extremity Function


III. Sensory


IV. Bladder Function


0.


Impossible to eat with either chopsticks or spoon


0.


Impossible to walk


A.


Upper extremity


0.


Complete retention


1.


Possible to eat with spoon, but not with chopsticks


1.


Need cane or aid as flat ground



0. Apparent sensory loss


1.


Severe disturbance


2.


Possible to eat with chopsticks, but inadequate


2.


Need cane or aid only on stairs



1. Minimal sensory loss



(1) Inadequate evaluation of the bladder


3.


Possible to eat with chopsticks, but awkward


3.


Possible to walk without cane or aid, but slow



2. Normal



(2) Straining


4.


Normal


4.


Normal


B.


Lower extremity



(3) Dribbling of urine







0. Apparent sensory loss


2.


Mild disturbance







1. Minimal sensory loss



(1) Urinary frequency







2. Normal



(2) Urinary hesitancy






C.


Trunk







0. Apparent sensory loss


3.


Normal







1. Minimal sensory loss







2. Normal




From Wada E, Suzuki S, Kanazawa A, et al. Subtotal corpectomy versus laminoplasty for multilevel cervical spondylotic myelopathy. Spine 2001;26:1443.

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Jul 5, 2016 | Posted by in NEUROSURGERY | Comments Off on Neurologic and Functional Evaluation Outcomes Assessment Tools in Cervical Spine Surgery

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