assessment of outcome in shoulder arthroplasty

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TOTAL SHOULDER ARTHROPLASTY 0030-5898/98 $8.00 + .OO ASSESSMENT OF OUTCOME IN SHOULDER ARTHROPLASTY John E. Kuhn, MD, and Ralph B. Blasier, MD Dr. Ernest Anthony Codman, a pioneer in surgery and science of the shoulder, was also a pioneer in the field of outcomes research. In his landmark address to the Philadelphia County Medical Society in 1913, titled ”The Product of a Hospital,” Codman discussed many of the issues that have lately resurfaced with the recent interest in outcomes re~earch.~ He called for the standardization of reporting data, so that the work done at different hospi- tals could be compared. He discussed fiscal and clinical efficiency in the delivery of health care. He identified regional variation of medi- cal services and offered insight into the cause of such variation, and he stressed the funda- mental principle that the result to the patient is the central issue determining the outcome of medical or surgical treatment. These last two issues-recognition of regional variation and patient-based evaluation-are the foun- dations upon which the whole field of mod- ern outcomes research has been based. For many years Codman’s efforts were underap- preciated, yet these pivotal issues raised in 1913 are the same issues being examined to- day. Most of this material has been previously published as: Kuhn JE, Blasier RB Measuring outcomes in shoulder arthroplasty. Seminars in Arfhroplasfy 6245-264, 1995. It reappears here with permission of the editor of this vol- ume and the copyright holder. The recent emphasis on outcomes research stems from the impression that health care expenditures in the United States are exces- sive. Research conducted in the 1970s and 1980s demonstrated that there is significant regional variation in the use of certain medi- cal services. This implies that in high-utiliza- tion areas, inefficient or unnecessary services are being provided, and that in low-utiliza- tion areas, patients may not be receiving ade- quate medical care. In order to accurately as- sess this regional variation and the effect of our treatments on patients, outcomes research requires two major approaches, reflected in Codman’s original concepts. First, assess- ments must be standardized to allow for com- parison of data between institutions and treatment methods; and second, the assess- ments used for outcomes research should em- phasize the patient’s perception of the out- come of medical and surgical treatment. Although rarely done in the past, all assess- ments should be tested for reliability and va- lidity before clinical use.” Reliability ensures that repeated administrations of an assess- ment will give the same results. An assess- ment has test-retest reliability if it produces the same results when given different times under the same conditions. Internal reliability is present when an assessment evaluating similar conditions produces similar results. From the Section of Orthopaedic Surgery, Division of Sports Medicine, The University of Michigan Shoulder Group, The University of Michigan Medical School, Ann Arbor (JEK); and the Department of Orthopaedic Surgery, Wayne State University School of Medicine, Detroit (RBB), Michigan ORTHOPEDIC CLINICS OF NORTH AMERICA VOLUME 29 NUMBER 3 JULY 1998 549

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Page 1: ASSESSMENT OF OUTCOME IN SHOULDER ARTHROPLASTY

TOTAL SHOULDER ARTHROPLASTY 0030-5898/98 $8.00 + .OO

ASSESSMENT OF OUTCOME IN SHOULDER ARTHROPLASTY

John E. Kuhn, MD, and Ralph B. Blasier, MD

Dr. Ernest Anthony Codman, a pioneer in surgery and science of the shoulder, was also a pioneer in the field of outcomes research. In his landmark address to the Philadelphia County Medical Society in 1913, titled ”The Product of a Hospital,” Codman discussed many of the issues that have lately resurfaced with the recent interest in outcomes re~earch.~ He called for the standardization of reporting data, so that the work done at different hospi- tals could be compared. He discussed fiscal and clinical efficiency in the delivery of health care. He identified regional variation of medi- cal services and offered insight into the cause of such variation, and he stressed the funda- mental principle that the result to the patient is the central issue determining the outcome of medical or surgical treatment. These last two issues-recognition of regional variation and patient-based evaluation-are the foun- dations upon which the whole field of mod- ern outcomes research has been based. For many years Codman’s efforts were underap- preciated, yet these pivotal issues raised in 1913 are the same issues being examined to- day.

Most of this material has been previously published as: Kuhn JE, Blasier RB Measuring outcomes in shoulder arthroplasty. Seminars in Arfhroplasfy 6245-264, 1995. It reappears here with permission of the editor of this vol- ume and the copyright holder.

The recent emphasis on outcomes research stems from the impression that health care expenditures in the United States are exces- sive. Research conducted in the 1970s and 1980s demonstrated that there is significant regional variation in the use of certain medi- cal services. This implies that in high-utiliza- tion areas, inefficient or unnecessary services are being provided, and that in low-utiliza- tion areas, patients may not be receiving ade- quate medical care. In order to accurately as- sess this regional variation and the effect of our treatments on patients, outcomes research requires two major approaches, reflected in Codman’s original concepts. First, assess- ments must be standardized to allow for com- parison of data between institutions and treatment methods; and second, the assess- ments used for outcomes research should em- phasize the patient’s perception of the out- come of medical and surgical treatment.

Although rarely done in the past, all assess- ments should be tested for reliability and va- lidity before clinical use.” Reliability ensures that repeated administrations of an assess- ment will give the same results. An assess- ment has test-retest reliability if it produces the same results when given different times under the same conditions. Internal reliability is present when an assessment evaluating similar conditions produces similar results.

From the Section of Orthopaedic Surgery, Division of Sports Medicine, The University of Michigan Shoulder Group, The University of Michigan Medical School, Ann Arbor (JEK); and the Department of Orthopaedic Surgery, Wayne State University School of Medicine, Detroit (RBB), Michigan

ORTHOPEDIC CLINICS OF NORTH AMERICA

VOLUME 29 NUMBER 3 JULY 1998 549

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550 KUHN & BLASIER

Validity ensures that the assessments measure outcomes accurately. The three approaches used to measure validity are content validity, which determines if all of the important as- pects of a condition are covered by the assess- ment; criterion validity, which ensures that the scores produced by the assessment corre- late with accepted standards; and construct validity, which demonstrates that the assess- ment produces results consistent with the ex- isting understanding of the field, or with other assessments.

Current research efforts are directed toward the development of a single standard assess- ment that may be used to evaluate the out- come of patients who have undergone shoul- der arthroplasty. Currently, however, a consensus as to the best way to evaluate shoulder arthroplasty patients has not been reached, and several different assessments have been used (Table 1). Unfortunately, only a few of these assessments have been evalu- ated for reliability or validity. These assess- ments tend to fall into a hierarchy of the following three levels: general health assess- ments, global shoulder assessments, and dis- ease-specific evaluations. Each of these levels of assessment provides a different perspective on the patient’s outcome.

Table 1. SCORING SYSTEMS USED TO EVALUATE THE SHOULDER

Quality-of-Life Measures Quality-of-Life Index Quality-Adjusted Life Years

General Health Measures

Arthritis Impact Measurement Scale Nottingham Health Profile Sickness Impact Profile

Without Scoring Systems American Shoulder and Elbow Surgeons

Simple Shoulder Test

Severity Index for Chronically Painful Shoulders Swanson Score Hospital for Special Surgery Shoulder-Rating Score Hospital for Special Surgery Self-Administered

Questionnaire UCLA End-Result Score Constant Score American Shoulder and Elbow Surgeons Index Shoulder Pain and Disability Index Questionnaire on the Perceptions of Patients About

SF-36

Global Shoulder Assessments

Assessment

With Scoring Systems

Shoulder Surgery

Adapfed from Kuhn JE, Blasier RB: Measuring outcomes in shoulder arthroplasty. Seminars in Arthroplasty 6:245-264, 1995.

GENERAL HEALTH AND QUALITY OF LIFE ASSESSMENTS

The assessment of a patient’s general health and quality of life are important in under- standing the outcome of any medical or surgi- cal treatment. For example, a complicated transplant operation may be technically suc- cessful and could be reported as such, yet if the patient remains morbidly ill, depressed, and frequently hospitalized, this should not be considered an excellent outcome. General measures of health and quality of life are designed to study patient outcomes on a com- prehensive, whole-person scale.

In general, it has been very difficult to as- sess the quality of a patient’s life. However, two such measures seem to have gained some acceptance recently. The Quality-of-Life In- d e ~ ~ ~ is a scale that numerically rates five aspects of life, including activity, daily living, health, support, and outlook, and scores each on a 2-point scale. The Quality-of-Life Index was designed to assess the overall quality of life of patients with cancer and other chronic illnesses, and is not particularly sensitive for patients who are generally healthy and have a single arthritic joint.28 As such, the Quality- of-Life Index may not be sensitive enough to evaluate the effect that an arthroplasty of the shoulder has on the patient’s quality of life.

The Quality-Adjusted Life Years (QALY) a n a l y ~ i s ~ * ~ ~ is a measure of the patient’s over- all disability and distress. This analysis at- tempts to determine a global benefit measure- ment for any treatment by combining the value of the patient’s improvement in the quality of life and any extra life expectancy gained by the treatment. The numerical value generated can be used to compare different types of treatments for the same condition, and can be used as a means of determining the benefit derived from a medical treatment relative to its expense (Table 2).14,42,43 Unfortu- nately, this assessment is heavily dependent on increases in life expectancy derived from a treatment, and may not be applicable to measuring the effect of shoulder arthroplasty or other orthopedic treatment.28 Nevertheless, this measure has been used to assess the value of shoulder arthroplasty relative to the cost, and has been used to compare the calcu- lated value of other types of treatment for various disorders (see Table 2)?2, 43

Particularly in these days of financial re- straint, estimates such as these may be used

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ASSESSMENT OF OUTCOME IN SHOULDER ARTHROPLASTY 551

Table 2. COSTlBENEFlT ANALYSIS USlNG QALYs FOR VARIOUS MEDICAL AND SURGICAL TREATMENTS, IN US DOLLARS

Treatment QALYs Gained Total Cost’ CostlQ ALY

Scoliosis Surgery-Neuromuscular 17.01 4851 285 Shoulder Arthroplasty 0.945 972 1029

CABG for LMD 3.0 441 0 1470 Hemodialysis 6.405 13,225 2065 Kidney Transplant 7.77 16,132 2076 Scolioisis Surgery-Idiopathic 1.26 4851 3850 CABG for 2VD 1 .o 441 0 441 0 Ambulatory Peritoneal Dialysis 3.57 19,858 5562

Hip Arthroplasty 4.0 441 0 1102

~ ~~

‘Cost in Great Britain, displayed in 1986 US dollars. CABG for LMD = Coronary artery bypass graft for left main/disease; CABG for 2VD = coronary artery bypass graft for

2-vessel disease. Adapfed from Williams A: The importance of quality of life in policy decisions. In Walker SR, Rosser RM (eds): Quality of Life:

Assessment and Application. Lancaster, England, MTP Press, 1988, pp 279-290; and Gudex C: QALY‘s and their use by the Health Service, University of York, Center for Health Economics, Discussion Paper No 20, 1986.

to ration health care. In fact, this measure has already been used to ration the allocation of funds for specialty health care in Great Brit- ain.I4 Fortunately, at least in the United King- dom, shoulder arthroplasty compares favor- ably to other medical treatments, and may not be at risk for rationing.

Another type of measurement of a patient’s general situation is an assessment of the pa- tient’s perception of overall health. A number of these evaluations are available. An exam- ple is the widely published SF-36 question- naire,4O which measures eight different as- pects of health, scoring them on a 100-point scale. The aspects of general health included in the assessment are (1) limitations in physi- cal activities owing to health problems, (2) limitations in social activities owing to physi- cal or emotional problems, (3) limitations in usual role activities owing to physical health problems, (4) limitations in usual role activi- ties owing to mental health problems, (5) gen- eral mental health and well being, (6) bodily pain, (7) vitality, and (8) general health per- cep t ion~ .~~ Other measures, such as the Ar- thritis Impact Measurement the Not- tingham Health Profile,I5 and the Sickness Impact Profile; may be more relevant to or- thopedic treatments?, 23 However, because the SF-36 assessment has been well validated and has been successfully used to evaluate a num- ber of medical conditions, its use is increasing for the general health evaluation of patients with orthopedic conditions. However, regard- ing the shoulder, the SF-36 does not seem to correlate well with other measures of shoul- der and should not be used as the only measure of outcome to assess the results of shoulder arthroplasty.

GLOBAL OR UNIVERSAL SHOULDER ASSESSMENTS

instead of evaluating the general health or well-being of the patient, the next level of outcome assessment is more focused and lim- its the evaluation to the shoulder. A number of different global shoulder assessment meth- ods are summarized in Table 3. These assess- ments are designed to be applied to any dis- order of the shoulder, and have some application to shoulder arthroplasty patients. Some assessments produce a final numerical grade that allows statistical comparison of the overall preoperative and postoperative condi- tion of the shoulder and allow for comparison between different methods of treatment. Other assessments serve as guides, ensuring that none of the important elements in the evaluation of the outcome are neglected and, although comprehensive, may be lengthy and cumbersome. Other assessments for the shoulder take a different approach and are designed to be as simple as possible.

One major concern with these various as- sessments is that they are inconsistent, em- phasizing different components of shoulder well-being (Table 3). Whereas some scoring assessments place a majority of emphasis on the patient’s pain, others place more empha- sis on function or range of motion. This oc- curs because the investigator who has devel- oped each measure has a personal opinion on the best parameters to measure success. This bias determines the most important elements of the assessment. Because this bias exists, the scoring systems in use today are not compa- rable, and worse, they may not reflect the patient’s perspective of the outcome. For

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Table 3. POINT ALLOCATION FOR VARIOUS COMPONENTS OF GLOBAL SHOULDER SCORING SYSTEMS

System Pain (%) Motion (%) Strength (%) Function (%) Other (%) Total

Severity Index 30 (30) - 15 (15) 40 (40) Handicap 15 (15) 100 Swanson 10 (33.3) 10 (33.3) - 10 (33.3) - HSS 30 (30) 25 (25) 15 (15) 30 (30) - 100

Constant 15 (15) 20 (20) 25 (25) 20 (20) - 100

30

10 (28.6) 5 (14.3) 5 (14.3) 10 (28.6) Satisfaction 5 (14.3) 35

100 100

UCLA

ASES Index 50 (50) SPADI 38.4 - 61.6

- - 50 (50) - - -

Percentages indicate the relative weight given to each component of the scoring systems. From Kuhn JE, Elasier RE: Measuring outcomes in shoulder artroplasty. Seminars in Arthroplasty 6:245-264, 1995.

these reasons, no published scoring system has been universally accepted.32 The various global shoulder assessments that may apply to shoulder arthroplasty patients are dis- cussed individually later.

The Severity Index for Chronically Painful Shoulders

The Severity Index for Chronically Painful Shoulders, also known as the Shoulder Sever- ity Index, was developed by Patte to assess patients with painful shoulder disabilities of a chronic nature.27 This shoulder assessment allocates 30 points to pain, 40 points to func- tion, 15 points to strength, and 15 points to a visual analogue scale for daily handicap. Numerical adjustments are then made for painful chronic shoulders, and for elderly pa- tients with limited activity or prosthetic re- placements. This elaborate and fairly compli- cated rating system has been largely abandoned, because simpler systems seem to be just as discriminating in determining out- come.2o Nevertheless, this system was one of the first to correlate pain and functional limi- tations to specific parameters of daily living.

The Swanson Score

The scoring system proposed by Swanson and colleagues was originally used to evalu- ate results following arthroplasty of the shoulder using the Swanson Bipolar Im- plant.38 In this system, equal weighting of 10 points each is given to pain, range of motion, and activities of daily living for a total of 30 points. The system does not include assess- ments of strength or stability. This system considers flexion and abduction as the most important motions, and less emphasis is given to other motions. The division of this

assessment into poor, fair, good, and excellent results has been made arbitrarily, and the sys- tem has not been validated. For these reasons, this scoring system has not gained wide ac- ceptance for the general evaluation of the pa- tient with a shoulder arthroplasty.

The Hospital for Special Surgery System for Assessing Shoulder Function

The Hospital for Special Surgery Assess- ment? has been used primarily by the parent institution and has not gained wide accep- tance elsewhere. This scoring system places greatest emphasis on pain, but also gives sub- stantial emphasis to shoulder function. Un- fortunately, this assessment averages strength in all planes of motion and does not consider joint stability. This assessment does not distin- guish between active and passive ranges of motion, and range of motion testing is done without a defined reference point. In addi- tion, there is a great deal of overlap between different categories, and the way pain at rest is scored influences the score for pain with motion. The pain evaluation is not completed by the patient, but is completed by the evalu- ating physician, is subjective to the examiner, and is based on multiple parameters, all of which may introduce bias. Strength testing is somewhat subjective in its grading. The subjective nature of this scoring system makes it vulnerable to considerable interob- server variation, which makes it difficult to compare reports prepared at different institu- tions or by different clinicians.

Recently, the Hospital for Special Surgery has developed a patient self-administered questionnaire for the global assessment of the sho~1der.l~ The questionnaire includes many domains, which evaluate global function, pain, daily activities, recreational and athletic

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activities, work, satisfaction, and areas for im- provement. This questionnaire has demon- strated excellent validity, reliability, and re- producibility. It remains to be seen if this questionnaire will be adopted by the Ameri- can Shoulder and Elbow Surgeons or other groups and gain wide acceptance.

The UCLA Scores

Two scores for the shoulder have been em- ployed at the University of California at Los Angeles (UCLA). The UCLA Shoulder As- sessment was employed originally to evaluate outcome after shoulder arthroplasty and was first presented in 1981.2 The UCLA End-Re- sult Score is a modification of this scoring system and is similar, but was originally used to evaluate patients with rotator cuff pathol- ogy.'O The UCLA End-Result Score has a more detailed and easier-to-follow assessment for range of motion and strength than the origi- nal UCLA Score. The UCLA End-Result Score was one of the first scoring systems to include patient satisfaction in the evaluation criteria. Unfortunately, forward elevation (flexion) is the only maneuver tested for range of motion and strength. There is no specific evaluation of internal or external strength or motion. In addition, patients are awarded 5 points of a total of 35 points if they are "satisfied and better." It would seem that most patients would record that they are not satisfied before surgery and "satisfied and better" after sur- gery, even if they do not perform well clini- cally. This would automatically give patients a 5-point addition to the score when compar- ing preoperative scores to postoperative scores. One seventh of the total score is de- pendent upon this criteria, which may artifi- cially elevate the significance of any surgical result. With a total score of 35 points, there is little room for flexibility, and it remains possi- ble that minor alterations in function may drastically affect the final result. Finally, this assessment has not yet been validated. De- spite these shortcomings, the UCLA score is simple and easy to interpret and use, and is widely used.

The Constant Score

The Constant score is a general scoring sys- tem, and is one of the few scoring system that have been validated by testing normal

individuals as well as symptomatic patient^.^ In validating this test, it was found that the normal scores decrease with age and vary with gender, and scores should be adjusted for age and gender before reporting data. In addition to studies of validation, the Constant Scoring System has been reported to have low intraobserver error and to be reproduc- ible.I3 The Constant Score gives 35 points for the subjective assessment and 65 points for the objective assessment (Appendix 1). Previ- ous statistical work would suggest that this is a reasonable distribution?, 2o In this scoring system, pain and function are given less em- phasis, whereas range of motion has greater emphasis.

The European Shoulder and Elbow Society has adopted the Constant Scoring System, and outcomes data presented at meetings of that society must be presented using the Con- stant Score. However, the Constant score has not been widely used in published reports, especially in American journals. To perform this evaluation, strength is tested using a spring balance or Cybex (Cybex, USA, Ron- konkoma, NY) machine, and this may be somewhat cumbersome to perform in a busy clinical practice. In addition, the exact tech- nique used to measure strength is not well defined, and this has lead to confusion and misinterpretation.I2 The Constant scoring sys- tem is not thought to be sensitive enough to detect shoulder instability.1a For these reasons, the Constant score is not yet universally ac- cepted.

The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment and Shoulder Score Index

The Research Committee of the American Shoulder and Elbow Surgeons (ASES) has de- veloped a standardized method for evaluat- ing the (Appendix 2). This effort was undertaken to create a universal method to measure the condition of the shoulder that would be easy to use, would assess activities of daily living, and would include a subjec- tive component to be completed by the pa- tient. This assessment is based primarily on the early work of Neer25, 26; however, many other scoring systems were reviewed during the development of this assessment.', 7, lo, 16, 36

The subjective, or patient-completed assess- ment, includes an inquiry about pain, symp-

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554 KUHN & BLASIER

toms of instability, and activities of daily liv- ing. Both pain and instability are graded on a 10-point visual analogue scale. The functional assessment includes 10 questions regarding activities of daily living. The patient grades ability to perform each of these activities on a 4-point scale. The objective, physician-com- pleted part of the form reviews range of mo- tion, specific physical findings, strength, and stability. Range of motion is measured pas- sively and actively, using a goniometer, in forward elevation, cross-body adduction, ex- ternal rotation with the arm at the side, and external rotation with the arm at 90" of abduc- tion; and also assesses internal rotation at the levels of the spinous processes. Strength is measured using the five-level Medical Re- search Council grades in forward elevation, abduction, internal rotation, and external ro- tation. Instability is graded on a four-point scale in three planes-anterior, posterior, and inferior.

The Research Committee of the ASES has utilized components of this assessment to produce a score called the Shoulder Score Index. This scoring system uses the subjective visual analog scale for pain for 50% of the total score, and scores the activities of daily living questionnaire for the other 50%, pro- ducing a 100-point total.

Unfortunately, some concerns have been raised about the ASES Standardized Shoulder as~essment.'~, l8 Although motion is measured passively and actively, it is not clear whether this motion is measured in the sitting or su- pine position, which may affect the active range. Because motion is referenced to the thorax, in an attempt to negate spine motion, range measured in this system may appear greater than range of motion reported by other assessments. Internal rotation as mea- sured by the vertebral levels on the back may not be acc~rate.'~ Internal rotation measured with the arm at 90" of abduction was part of Neer's original evaluation, but was omitted from the ASES evaluation, presumably be- cause this position is difficult for many pa- tients.18 The clinical significance of this omis- sion is uncertain. Functional testing may be altered by elbow and wrist abnormalities, and may not reflect abnormalities in shoulder function when such elbow and wrist maladies exist. The ASES Standardized Shoulder As- sessment does not include any information regarding radiographic findings. The ASES Standardized Shoulder Assessment, unlike the Neer evaluation, does not include a sub-

jective measure of improvement or satisfac- tion with treatment, which might be helpful in serial evaluations and would be important in assessing the patient's perception of the outcome of treatment. Finally, because the scoring index may not be sensitive enough to detect some specific disorders of the shoulder, such as instability, it is recommended that the criteria in the ASES Standardized Shoulder Assessment be described when reporting data. Realizing these limitations, the Research Committee has recommended modifying or customizing their assessment to fit individual clinician needs, so that any specific or un- usual conditions can be addressed.

The Simple Shoulder Test

Matsen and colleagues at the University of Washington have developed a system to as- sess the functional status of the shoulder.16, 21,22 Their goals were to create a simple, quick, and inexpensive evaluation that could be used in any practice. They emphasize the en- tirely subjective nature of the questionnaire, which was developed to eliminate any physi- cian-induced bias. The Simple Shoulder Test consists of 12 yes-or-no questions. Patients can complete this questionnaire in the office or at home, and mail or fax it back to the office, which hopefully improves follow-up. Data generated by the Simple Shoulder Test may be helpful in the informed consent pro- cess, by letting patients know before surgery which functional tasks are likely to improve after a given procedure.

In trials at the University of Washington, the Simple Shoulder Test has fulfilled many of its objectives.'6, 22 However, it has problems which may limit its usefulness. The binary response reduces variability in the answers to the questions, may make statistical evaluation difficult. Patients who have mild pain with

, the arm at the side would answer the same as patients with incapacitating pain. The questions in the evaluation were chosen by reviewing other scoring systems and re- viewing patient responses at the University of Washington, and may not represent other populations, such as athletes with shoulder problems. The symptoms of pain, instability, and weakness are evaluated indirectly through the questions, which address the ability to perform different activities. There are no questions regarding the patient's sub- jective overall impression of the outcome of

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ASSESSMENT OF OUTCOME IN SHOULDER ARTHROPLASTY 555

treatment. Because there is no scoring system and little patient input regarding level of sat- isfaction, it becomes difficult to divide pa- tients into excellent, good, fair, and poor out- comes. Overall, its simplistic nature may be both the greatest strength and greatest fault of this assessment.

The Shoulder Pain and Disability Index and the Questionnaire on the Perceptions of Patients About Shoulder Surgery

Like the Simple Shoulder Test, the Shoulder Pain and Disability Index (SPADI)31 and the Questionnaire on the Perceptions of Patients About Shoulder Surgery (QPPASS)8 are pa- tient self-administered questionnaires that in- vestigate the patient's perception of the shoul- der. The SPADI evaluation uses visual analogue scales to rate the patient's response to 13 questions, of which 5 evaluate pain and 8 evaluate disability. The questions are then scored and are separately totalled for pain and disability. The pain score and the disabil- ity score are then averaged. Similarly, the QPPASS uses 12 questions about shoulder function in a similar way. The QPPASS does not use visual analogue scales, but rather a five-level range of answers for each question. Both of these assessments have been vali- dated and have been found to be reliable, with excellent criterion and construct validity.8, 31 It remains to be seen whether ei- ther of these assessments will gain wide ac- ceptance in the orthopedic community.

ASSESSMENTS FOR SPECIFIC DISEASE STATES THAT MAY BE TREATED WITH SHOULDER ARTHROPLASTY

The next level of assessment is the most sensitive, and focuses on specific disorders of the shoulder. For example, there are evalua- tion systems for assessing the outcome after instability 39 and impingement sur- gery.' Regarding disease states treated by elective shoulder arthroplasty, such as rheu- matoid arthritis, degenerative joint disease, and avascular necrosis, there are no specific evaluations available. Because there are many indications for shoulder arthroplasty, it is in- appropriate to combine all patients who have undergone a shoulder arthroplasty into one

group. Patients with osteoarthritis require dif- ferent surgical techniques and have different goals and outcomes than patients with frac- tures or even rotator cuff tear arthropathy. To accurately assess outcomes at this level, specific assessments for different disease states treated by shoulder arthroplasty need to be developed and employed.

THE FUTURE OF EVALUATING SHOULDER ARTHROPLASTY OUTCOMES AND RECOMMENDATIONS

As the field of outcomes research advances, a consensus may eventually be reached on the most appropriate method to assess the results and effectiveness of shoulder arthroplasty. The most appropriate assess- ment must include the patient's perception of the outcome. Scoring systems should place emphasis on the factors contributing to shoul- der well-being, according to the relative im- portance of these components as assigned by the patients. Currently, there is an effort to determine appropriate patient-derived levels of emphasis. Until this is completed, assess- ments of the shoulder will be plagued by evaluator bias.

With regard to the level of sensitivity of the different evaluations available, we believe that no one type of evaluation will prove to be adequate for all purposes. Instead, data will have to be presented using all three levels of evaluation, including (1) general health or quality of life assessments, (2) global shoulder assessments, and (3) assessments specific to the shoulder pathology under evaluation. At- tempts to simplify these levels of complexity will cause loss of sensitivity and may not reflect the outcome of shoulder arthroplasty adequately. The SF-36 general health assess- ment is gaining popularity in orthopedics, and should probably be included in the as- sessment of patients undergoing shoulder arthroplasty. With regard to global shoulder assessments, the ASES evaluation (see Ap- pendix 2) is currently preferred when pres- enting data in the United States, and the Con- stant assessment (see Appendix 1) should be used when presenting results in Europe. Al- though the other assessments reviewed in this article have merit, there is a growing consen- sus toward the use of these two global shoul- der evaluations. For the practicing physician, the ASES assessment is recommended, as it

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is not very complicated, but is comprehensive enough to allow comparison of personal data with data presented in published reports.

Finally, there is no consensus, and, in fact, there are no specific assessments available to review the shoulder with glenohumeral ar- thritis or the shoulder with humeral head fractures. As these indications for glenohu- meral arthroplasty are very different, differ- ent outcomes should be expected, and differ- ent assessments are required to evaluate outcomes. A humeral head fracture assess- ment should be developed to compare the different methods of treating fractures, and a separate glenohumeral arthritis assessment is needed to compare different methods of treat- ing arthritis. These two vastly different condi- tions should not be combined merely because their treatment is similar. To fully understand a disease, the pathologist looks at the organ macroscopically and the specimen microscop- ically with both low- and high-power lenses. So too should assessments of the shoulder be made.

References

1 . Altchek DW. Warren RF. Wickiewicz TL, et al:

2.

3.

4.

5.

6

7

8.

9.

10.

11.

Arthroscopic acromioplasty. Technique and results. J Bone Joint Surg 72A:1198-1207, 1990 Amstutz HL, Sew Hoy AL, Clark I C UCLA anatomic total shoulder arthroplasty. Clin Orthop 155:7-20, 1981 Beaton DE, Richards RR: Measuring shoulder func- tion: A cross-sectional comparison of five question- naires. J Bone Joint Surg Am 78A882-908, 1996 Bergner M, Bobbitt RA, Carter WB, et al: The sickness impact profile: Development and final revisions of a health status measure. Med Care 19:787-805, 1981 Codman E A The product of a hospital. Surg Gynecol Obstet 18:491496, 1914 Constant CR Age related recovery of shoulder func- tion after injury [thesis]. Cork, Ireland, University College, 1986, Constant CR, Murky AHG: A clinical method of functional assessment of the shoulder. Clin Orthop 21416G164, 1987 Dawson J, Fitzpatrick R, Carr A Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br 78B593400,1996 Deyo RA, Inui TS, Leininger JD, et al: Measuring functional outcome in chronic disease: A comparison of traditional scales and a self administered health status questionnaire in patients with rheumatoid ar- thritis. Med Care 21:180-192, 1983 Ellman H, Hanker G, Bayer M Repair of the rotator cuff End-result study of factors influencing recon- struction. J Bone Joint Surg 68A:113644, 1986 Fitzpatrick R Patient Satisfaction and Quality of Life Measures. In Pynsent P, Fairbank J, Carr A (eds): Outcome Measures in Orthopaedics. Oxford, Butter- worth-Heinemann, 1993, pp 45-58

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.

29.

Gerber C Latissimus dorsi transfer for the treatment of irreparable tears of the rotator cuff. Clin Orthop

Gerber C Integrated Scoring Systems for the Func- tional Assessment of the Shoulder. In Matsen FA 111, Fu FH, Hawkins RJ (eds): The Shoulder: A Balance of Mobility and Stability. Rosemont, IL, American Academy of Orthopaedic Surgeons, 1993, pp 531-550 Gudex C: QALYs and their use by the Health Service. University of York, Centre for Health Economics, Discussion Paper No. 20, 1986 Hunt SM, McEwen J, McKenna SP: Measuring health status. A new tool for clinicians and epidemiologists. Policy Statement R Coll Gen Pract 35:185-188, 1985 Lippitt SB, Harryman DT 11, Matsen FA I11 A Practi- cal Tool for Evaluating Function: The Simple Shoul- der Test. In Matsen FA 111, Fu FH, Hawkins RJ (eds): The Shoulder: A Balance of Mobility and Stability. Rosemont, Ill, American Academy of Orthopaedic Surgeons, 1993, pp 501-518 L‘Insalata JC, Warren RF, Cohen SB, et al: A self administered questionnaire for assessment of symp- toms and function of the shoulder. J Bone Joint Surg Am 79A738-748, 1997 MacDonald DA: The Shoulder and Elbow. In Pynsent P, Fairbank J, Carr A (eds): Outcome Measures in Orthopaedics. Oxford, Butterworth-Heinemann, 1993, pp 144-173 Mallon WJ, Herring CL, Sallay PI, et a1 Use of verte- bral levels to measure presumed internal rotation at the shoulder: A radiographic analysis. J Shoulder Elbow Surg 5299-306,1996 Marechal E: Ruptures degeneratives de la coiffe des rotateurs l’epaule: Evaluation foncitionnelle: Re- sultats du traitement chirurgical. Universite Claude Bernard, Lyon I, France, Facultee de Medecine Grange, Blanche, These No. 5, 1990 Matsen FA, Lippitt SB, Sidles JA, et al: Evaluating the Shoulder. In Matsen FA, Lippitt SB, Sidles JA, et a1 (eds): Practical Evaluation and Management of the Shoulder. Philadelphia, WB Saunders, 1994, pp 1-17 Matsen FA, Ziegler DW, BeBartolo SE Patient self- assessment of health status and function in glenohu- meral degenerative joint disease. J Shoulder Elbow Surg 4345-351, 1995 McDowell IW, Martini CJM, Waugh WA A method for self-assessment of disability before and after hip replacement operations. BMJ 28574359,1978 Meenan RF, Gertman PM, Mason JH, et al: The arthri- tis impact measurement scales: Further investigation of a health status measure. Arthritis Rheum 251048- 1053, 1982 Neer CS II: Anterior acromioplasty for the chronic impingement syndrome in the shoulder: A prelimi- nary report. J Bone Joint Surg 54A41-50,1972 Neer CS 11, Watson KC, Stanton FJ: Recent experience in total shoulder replacement. J Bone Joint Surg

Patte D Directions for the use of the index severity for painful and/or chronically disabled shoulders [Abstract]. Abstracts of the First Open Congress of the European Society of Surgery of the Shoulder and the Elbow. Paris, 1987, pp 36-41 Radford PJ: General Outcome Measures. In Pysnet P, Fairbank J, Carr A (eds): Outcome Measures in Orthopaedics. Oxford, England, Butterworth-Heine-

Richards RR, An KN, Bigliani LU, et al: A standard method for the assessment of shoulder function. J Shoulder Elbow Surg 397-352,1994

275152-160, 1992

64A:319-337,1982

m, 1993, pp 59-80

Page 9: ASSESSMENT OF OUTCOME IN SHOULDER ARTHROPLASTY

ASSESSMENT OF OUTCOME IN SHOULDER ARTHROPLASTY 557

30. Richards RR, Beaton DE: Measuring shoulder func- tion: A cross-sectional comparison of five different questionnaires. J Shoulder Elbow Surg 4(part 2):561, 1994

31. Roach KE, Budiman-Mak E, Songsiridej N, et al: De- velopment of a shoulder pain and disability index. Arthritis Care and Res 4(4):143-149, 1991

32. Romeo AA, Bach BR, OHalloran KL: Scoring sys- tems for shoulder conditions. Am J Sports Med 24(4):472476, 1996

33. Rosser R, Watts V The measurement of hospital out- put. Int J Epidemiol 1:361-368, 1972

34. Rosser R, Kind P: A scale of valuations of states of illness: Is there a social consensus? Int J Epidemiol

35. Rosser R From Health Indicators to Quality Adjusted Life Years: Technical and Ethical Issues. In Hopkins A, Costain D (eds): Measuring Outcomes of Medical Care. London, Royal College of Physicians, 1990,

36. Rowe CR, Pate1 D, Southmayd WW: The Bankart procedure: A long-term end-result study. J Bone Joint Surg 60A:1-16,1978

37. Spitzer WO, Dobson AJ, Hall J, et a1 Measuring the

7347-358, 1978

pp 51-73

quality of life of cancer patients: A concise QL-Index for use by physicians. J C h o n Dis 54:585-597, 1981

38. Swanson AB, DeGroot Swanson G, Sattel AB, et al: Bipolar implant shoulder arthroplasty. Clin Orthop 249:227-247, 1989

39. Walch G: Directions for use of the quotation of ante- rior instabilities of the shoulder. First Open Congress of the European Society of Surgery of the Shoulder and Elbow. Paris, 1987, pp 51-55

40. Ware JE, Shervoume CD: The MOS 36-item short- form health survey (SF-36): I. Conceptual framework and item selection. Med Care 30:473-483, 1992

41. Warren RF, Ranawat CS, Inglis AE: Total Shoulder Replacement. Indications and Results of the Neer Nonconstrained Prosthesis. In Inglis AE (ed): Ameri- can Academy of Orthopaedic Surgeons: Symposium on Total Joint Replacement of the Upper Extremity. St. Louis, CV Mosby, 1982, pp 56-67

42. Williams A Economics of coronary artery bypass grafting. BMJ 291:325329, 1985

43. Williams A: The Importance of Quality of Life in Policy Decisions. In Walker SR, Rosser RM (eds): Quality of Life: Assessment and Application. Lancas- ter, England, MTP Press, 1988, pp 279-290

Address reprint requests to

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APPENDIX 1

The Constant Score

Pain Score (15 points maximum)

None Mild Moderate Severe

15 1 0 5 0

Activities of Daily Living (20 points maximum)

Activity Level (10 points) Full Work 4 Full RecreationlSport 4 Unaffected Sleep 2

Positioning (1 0 points) Up to Waist Up to Xiphoid Up to Neck Up to Top of Head Above Head

2 4 6 8 1 0

Range of Motion (40 points maximum)

Forward Elevation (1 0 points) and Lateral Elevation (1 0 points) 0-30" 0 31 "-60" 2 61 "-90" 4 91 "-1 20" 6 121 "-1 5 0 " 8 151"-180" 1 0

External Rotation (1 0 points) Hand behind head, elbow forward Hand behind head, elbow back Hand to top of head, elbow forward Hand to top of head, elbow backward Full elevation from to of head

2 2 2 2 2

Internal Rotation (1 0 points) Lateral thigh 0

Lumbosacral junction 4 Buttock 2

Waist (L3 vertebral body) 6 T12 vertebral body 8 lnterscapular (T7 vertebral body) 1 0

Strength of Abduction (25 points maximum) 1 point/lb

From Constant CR, Murley AHG: A clinical method of functional assessment of the shoulder. Clin Orthop 214160-164, 1987; with permission.

559

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APPENDIX 2

The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment and

Shoulder Score Index Name Date Age- Hand Dominance R- L- Ambi- Sex M F- Diagnosis Initial Assess? Y- N- Procedure/Date FOIIOW-UP M- Y-

PATIENT SELF-EVALUATION

Are you having pain in your shoulder (circle correct answer) Mark where your pain is

Yes- No-

Do you have pain in your shoulder at night? Do you take pain medication (aspirin, Advil, Tylenol etc.)? Do you take narcotic pain medication (codeine or stronger)? How many pills do you take each day (average)? How bad is your pain today (mark line)?

Yes- No- Yes- No- Yes- No-

pi l ls

I I I I I I I I I I I No pain at all Pain as bad as it can be

Does your shoulder feel unstable (as if it is going to dislocate)? Yes- How unstable is your shoulder (mark line)?

I I I I I I I I I I I Very stable Very Ustable

No-

Circle the number that indicates your ability to do the following activities: 0 = unable to do; 1 = very difficult to do; 2 = somewhat difficult; 3 = not difficult

Activity 1. Put on a coat 2. Sleep on your painful or affected side 3. Wash back/do up bra in back 4. Manage toileting 5. Comb hair 6. Reach a high shelf 7. Lift 10 Ib above shoulder 8. Throw a ball overhand 9. Do usual work - List: 10. Do usual sport - List:

Right Arm 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3

Left Arm 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3

561

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562 KUHN & BLASIER

PHYSICIAN ASSESSMENT

RANGE OF MOTION RIGHT Total motion with goniometer active passive Forward elevation (max. arm trunk angle)

External rotation (arm at side)

External rotation (arm at 90" abduction)

Internal rotation (highest with thumb)

Cross-body adduction

SIGNS

SIGN RIGHT O= none; I = mild; 2 = moderate; 3 = severe

Supraspinatudgreater tuberosity tenderness 0 1 2 3 AC joint tenderness 0 1 2 3 biceps tendon tenderness (or rupture) 0 1 2 3 Other tenderness - List: 0 1 2 3 Impingement I (passive FE in slight internal rot) Y N Impingement I1 (passive internal rotation, 90" FE) Y N Impingement I l l (90" active abduction/painful arc) Y N Subacromial crepitus Y N Scars - location Y N Atrophy - location Y N Deformity - describe: Y N

LEFT active passive

LEFT 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 Y N Y N Y N Y N Y N Y N Y N

STRENGTH (MRC grade ) 0 = no contraction; 1 = flicker; 2 = movement with gravity; 3 = movement against gravity; 4 = movement against some resistance; 5 = normal power

RIGHT LEFT Testing affected by pain? Y N Y N Forward elevation 0 1 2 3 4 5 0 1 2 3 4 5 Abduction 0 1 2 3 4 5 0 1 2 3 4 5 External rotation (arm at side) 0 1 2 3 4 5 0 1 2 3 4 5 Internal rotation (arm at side) 0 1 2 3 4 5 0 1 2 3 4 5

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ASSESSMENT OF OUTCOME IN SHOULDER ARTHROPLASTY 563

INSTA B I LlTY 0 = none; 1 = mild (0- to 1-cm translation); 2 = moderate (1- to 2-cm translation); 3 = severe (>2 cm translation or over the rim of the glenoid)

SIGN Anterior translation Posterior translation Inferior translation (sulcus sign) Anterior apprehension Reproduces symptoms? Voluntary instability? Relocation test positive? Generalized ligamentous laxity?

RIGHT 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 Y N Y N Y N Y N

LEFT 0 1 2 3 0 1 2 3 0 1 2 3 0 1 2 3 Y N Y N Y N Y N

Other physical findings:

Examiner's name Date

(The Shoulder Score Index is derived as: 5 x (10-visual analogue scale pain score) + (53 x Cumulative ADL Score) and has a maximum total of 100 points.)

From Richards RR, An KN, Bigliani LU, et al: A standard method for the assessment of should function. J Shoulder Elbow Surg 3347-352. 1994; with permission.