Patient-reported outcome measures used for shoulder disorders: An overview of systematic reviews

BackgroundThe aim of this study was to synthesize the psychometric evidence on different patient reported outcome measures (PROMs) for shoulder disorders.MethodsThis overview conducted a search of six databases. Included systematic reviews must address at least one psychometric property from a PROM for shoulder disorders. Risk of bias was assessed by A MeaSurement Tool to Assess Systematic Reviews (AMSTAR).ResultsThirteen systematic reviews were identified that assessed measurement properties of 15 different PROMs. Based on AMSTAR, 1 review had a high risk of bias and 7 reviews had a moderate risk of bias. Excellent test-reliability scores of intraclass correlation coefficients (0.85-0.99) were reported by the Disabilities of the Arm, Shoulder and Hand, Shoulder Pain and Dsiability Index, American Shoulder and Elbow Surgeon score and Western Ontario Rotator Cuff Index. Construct validity was supported (r = 0.5-0.8) for the Disabilities of the Arm, Shoulder and Hand, Shoulder Pain and Dsiability Index, American Shoulder and Elbow Surgeon score and Western Ontario Rotator Cuff Index. Limited evidence of responsiveness was reported across various PROMs.ConclusionStrong reliability and convergent validity properties have been reported across multiple reviews for the Disabilities of the Arm, Shoulder and Hand, Shoulder Pain and Dsiability Index, American Shoulder and Elbow Surgeon score, Simple Shoulder Test and Western Ontario Rotator Cuff Index, which could be considered for a core clinical outcome set.     

Analysis of Evidence-Based Medicine for Shoulder Instability

Clinical research has become a major influencing factor in the determination of treatment choice in our society. Outcome data have been requested by third-party payers, patients, and administrators alike. Currently, there are over 10 different scoring systems that have been used to evaluate the efficacy of treatment for shoulder instability. Some of these scoring systems are based on the specific condition of shoulder instability; however, other systems are broadly based to incorporate a spectrum of shoulder conditions. This review summarizes the process of proper development and testing of the scoring systems, discusses their role in clinical research with respect to shoulder instability, and explains the dichotomy of postoperative recurrence of instability and high shoulder scores. The Shoulder Rating Questionnaire (SRQ), Melbourne Instability Shoulder Score (MISS), Western Ontario Shoulder Instability Index (WOSI), Oxford Instability Score (OIS), and Simple Shoulder Test were shown to be reliable for patients with instability. The SRQ, MISS, WOSI, OIS, and American Shoulder and Elbow Surgeons score have all been shown to be largely responsive. There are 2 shoulder scoring systems, the WOSI and the MISS, that we recommend be used to evaluate shoulder instability. The SRQ and OIS were found to be less responsive for patients with instability compared with patients with other shoulder dysfunctions. Other scoring systems lack inter-rater reliability, validity, and/or responsiveness for patients in the instability population. The optimal scoring system for patients with upper extremity problems other than those with shoulder instability has yet to be determined; however, the American Shoulder and Elbow Surgeons score may be considered, because this instrument has been proven to be valid, reliable, and responsive.     

Measurement properties of the Western Ontario rotator cuff outcome measure: a preliminary report

The purpose of this prospective repeated-measures outcomes study was to investigate the construct validity and sensitivity to change of a newly developed outcome measure, the Western Ontario Rotator Cuff Index (WORC) in a population of patients seen at a tertiary shoulder center. A total of 154 subjects (66 women and 88 men; mean age, 48 years [SD, 14.80 years]) agreed to participate in the study. Of these, 50 patients (16 women and 34 men; mean age, 50 years [SD, 14.36 years]) met the criteria for surgery. The Pearson correlation coefficients between the initial scores and the change scores at 6 months postoperatively of the WORC, Constant-Murley shoulder form, and American Shoulder and Elbow Surgeons standardized shoulder assessment form were high (P < .01). The WORC was sensitive to detect change: F = 28.041 and P < .000 at 3 months and F = 66.927 and P < .000 at 6 months postoperatively. The results of this study support the validity of the WORC for use in patients with rotator cuff pathology.     

The factor validity of the Western Ontario Rotator Cuff Index

Background  

The Western Ontario Rotator Cuff Index (WORC) is a self-report questionnaire developed specifically to evaluate disability in persons with pathology of the rotator cuff of the shoulder. The authors created items in 5 categories based on a model of quality of life, but never validated this structure. The purpose of this study was to examine the validity of the original 5-domain model of the WORC by performing factor analysis.     

Translation and psychometric testing of the Western Ontario Rotator Cuff Index (WORC) for use in Germany

AIM: At the moment a specific subjective measurement tool for evaluation of German-speaking patients with a pathology of the rotator cuff is lacking. Following international guidelines, the German translation and the psychometric testing of the 21-item, multidimensional Western Ontario Rotator Cuff Index (WORC) is the aim of the study. METHOD: After translation and cross-culture adaptation of the English original, the reliability, validity, practicability and the acceptance of the German version of the WORC were tested on 102 patients with an impingement syndrome. Additionally the SF-36, the Constant and UCLA score were evaluated. RESULTS: The Pearson correlation coefficient showed with 0.96 an excellent result for the test-retest reliability. The internal consistency showed a high homogeneity with a Cronbach alpha coefficient of 0.96. A Pearson correlation coefficient between 0.66-0.81 registered a high correlation with the physical subscales of the SF-36, the Constant and the UCLA score. The mean time required for filling out the WORC was 7.5 minutes, the mean time required for evaluation was 10 minutes. The acceptance and the understanding were very high. CONCLUSION: After successful translation and psychometric testing of the German version of the Western Ontario Rotator Cuff Index (WORC), a patient-based measurement tool for evaluating the quality of life of German-speaking patients with pathology of the rotator cuff is available.     

Measuring shoulder injury function: common scales and checklists

The increasing shift towards patient-centred healthcare has lead to an emergence of patient-reported outcome instruments to quantify functional outcomes in orthopaedic patients. Unfortunately, selecting an instrument for use in a shoulder trauma population is often problematic because most shoulder instruments were initially designed for use with chronic shoulder pathology patients. To ensure an instrument is valid, reliable, and sensitive to clinical changes, it is important to obtain psychometric evidence of its use in the target population.Four commonly used shoulder outcome instruments are reviewed in this paper: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES); Constant-Murley shoulder score (CMS); Disabilities of Arm, Shoulder, and Hand (DASH); Oxford Shoulder Score (OSS). Each instrument was reviewed for floor or ceiling effects, validity, reliability, responsiveness, and interpretability. Additionally, evidence of each instrument's psychometric properties was sought in shoulder fracture populations.Based on the current literature, each instrument has limited amounts of evidence to support their use in shoulder trauma populations. Overall, psychometric evaluations in isolated shoulder fracture populations remain scarce, and clinicians must remember that an instrument's properties are defined for the population tested and not the instrument. Therefore, caution must always be exercised when using an instrument that has not been fully evaluated in trauma populations.     

The Munich Shoulder Questionnaire (MSQ): development and validation of an effective patientreported tool for outcome measurement and patient safety in shoulder surgery

ABSTRACT: BACKGROUND: Outcome measurement in shoulder surgery is essential to evaluate the patient safety and treatment efficiency. Currently this is jeopardized by the fact that most patient-reported selfassessment instruments are not comparable. Hence, the aim was to develop a reliable selfassessment questionnaire which allows an easy follow-up of patients. The questionnaire also allows the calculation of 3 well established scoring systems, i.e. the Shoulder Pain and Disability Index (SPADI), the Constant-Murley Score (CMS), and the Disabilities of the Arm, Shoulder and Hand (DASH) Score. The subjective and objective items of these three systems were condensed into a single 30-questions form and validated against the original questionnaires. METHODS: A representative collective of patients of our shoulder clinic was asked to fill in the newly designed self-assessment Munich Shoulder Questionnaire (MSQ). At the same time, the established questionnaires for self-assessment of CONSTANT, SPADI and DASH scores were handed out. The obtained results were compared by linear regression analysis. RESULTS: Fifty one patients completed all questionnaires. The correlation coefficients of the results were r = 0.91 for the SPADI, r = -0.93 for the DASH and r = 0.94 for the CMS scoring system, respectively. CONCLUSIONS: We developed an instrument which allows a quantitative self-assessment of shoulder function. It provides compatible data sets for the three most popular shoulder function scoring systems by one single, short 30-item. This instrument can be used by shoulder surgeons to effectively monitor the outcome, safety and quality of their treatment and also compare the results to published data in the literature.     

Outcome instruments for patellofemoral arthroplasty

Although there are numerous patient outcome instruments available, the most reliable and valid instruments for evaluating patient outcomes after patellofemoral arthroplasty have not been identified. In this article, we review and evaluate the psychometric properties and practical considerations of administering general health instruments (Medical Outcomes Study (MOS) Short Form-36 and Short Form-12), knee scales (Knee Society Clinical Rating System, Knee Outcome Survey, International Knee Documentation Committee form, Knee Injury and Osteoarthritis Outcome Score) and a disease specific scale (Western Ontario and McMaster Universities Osteoarthritis Index) for patellofemoral arthroplasty outcome assessment. Based on our review of the literature, we recommend the Short Form-36 and Knee Injury and Osteoarthritis Outcome Score for evaluation of patellofemoral arthroplasty outcomes and provide recommendations for implementation of these instruments in a clinical setting.     

Assessing the reliability and responsiveness of 5 shoulder questionnaires

The purpose of this study was to compare the test-retest reliability and responsiveness of 5 different shoulder questionnaires in a simple of patients with shoulder pain. Ninety-nine patients completed the following shoulder questionnaires on 2 occasions: Subjective Shoulder Rating Scale, Simple Shoulder Test, Modified-American Shoulder and Elbow Surgeons Form, Shoulder Severity Index, and the Shoulder Pain and Disability Index. The Short Form-36 was also included. Test-retest reliability was assessed with intraclass correlation coefficients. Standardized response means were calculated to assess responsiveness. This procedure was done on 33 subjects who underwent rotator cuff surgery or total shoulder arthroplasty and who believed that they had improved between testings. All questionnaires had acceptable reliability (coefficients >0.75) except the Subjective Shoulder Rating Scale (coefficient = 0.71) and were more responsive (0.65 < Standardized response mean < 1.23) than the Short Form-36 (0.08 < Standardized response mean < 0.43) except for pain (0.91). In this longitudinal study a direct comparison of 5 shoulder questionnaires was carried out. We found the Subjective Shoulder Rating Scale to have lower reliability and responsiveness. The other 4 questionnaires including 1 developed to measure whole extremity function (Modified American Shoulder and Elbow Surgeons Form) rather than the shoulder only were comparable with good reliability and responsiveness. The results indicate that the shoulder questionnaires were more sensitive to change in patients with shoulder pain than the generic questionnaire (Short Form-36), and both types of questionnaires should be used in outcome evaluations.     

Outcomeanalyse nach offener Rekonstruktion von Rotatorenmanschettenrupturen Eine vergleichende Beurteilung neuer Bewertungsverfahren

Outcome evaluation is becoming increasingly important for reconstructive surgery in musculoskeletal diseases. In addition to established shoulder-scores, new outcome-scores are being developed to cover all effects caused by a disease or intervention. Three validated, self-administered shoulder questionnaires were applied prospectively in 23 otherwise healthy patients suffering from rotator cuff deficiency. These were correlated to the Constant-Murley Shoulder Score and to a visual analogue scale for satisfaction. 7 women and 16 men with combined tears of supraspinatus and infraspinatus (mean age 55.3 +/- 10.5, r/l: 14/9, FU 57.8 +/- 15.7 weeks) were gathered prospectively and evaluated pre- and postoperatively with the American Shoulder and Elbow Surgeons Shoulder Index (ASES), the Simple Shoulder Test (SST) and the Disabilities of the Arm, Shoulder and Hand Module (DASH questionnaire). In addition, a visual analogue scale for satisfaction was employed. All four scores as well as the visual analogue scale revealed improvement at a statistically significant level (paired, two-tailed t-test, P < 0.01) after surgery. All questionnaires had a significant correlation with the Constant-Murley Shoulder Score (Pearson's correlation coefficient: ASES: r = 0.871, P < 0.01; DASH: r = -0.758, P = < 0.01; SST: r = 0.494, P < 0.05). All were easy to apply and provided a reliable, postoperative evaluation of shoulder function. The SST was easy to apply, however compound outcome analysis was only possible with the ASES Shoulder Index and the DASH questionnaire. The DASH scale was the most complex evaluation instrument. The Constant-Murley Shoulder Score comprises a physical examination which is advantageous but must be carried out in the clinic. For postoperative assessment, without the patient having to return to the clinic, the ASES Shoulder Index is preferred as it correlates well with the Constant-Murley Shoulder Score (r = 0.871) and the visual analogue scale for satisfaction (r = 0.762).     

Biographical Sketch: Paul M. Grammont,MD (1940)

This biographical sketch on Paul M. Grammont corresponds to the historic text, The Classic: Delta Shoulder Prosthesis for Rotator Cuff Rupture (1993), available at DOI .     

Functional outcome after proximal humeral fractures treated with hemiarthroplasty

Objective

To evaluate functional outcome after hemiarthroplasty for displaced proximal humeral fractures and to review whether prosthesis type, intraoperative technique or previous ipsilateral shoulder surgery could affect the outcome.

Methods

We reviewed the medical records and radiographs of patients who had undergone hemiarthroplasty for proximal humeral fractures between 1992 and 2000. We identified 45 patients, 39 with acute fractures and 6 with fracture-related complications. One surgeon performed 17 surgeries (38%), and the rest were carried out by 11 other orthopedic surgeons. Using the American Shoulder and Elbow Surgeons Evaluation Form and the Western Ontario Rotator Cuff Index, we evaluated patients who had been followed for at least 2 years for residual shoulder pain, range of motion, strength, stability and function. The senior authors reviewed the radiographs.

Results

The mean age of the patients at presentation was 70 (range 46–95) years. The mean active forward elevation was 87°, abduction 63° and external rotation 22°; the mean internal rotation was to the L2 vertebra. Of the patients, 15% reported severe pain, and 25% were unable to sleep on the affected side. Patients with previous surgeries and those with intraoperative cuff tears were found to have more postoperative pain.

Conclusion

We conclude that soft tissue status and operative technique play an important role in late postoperative pain and range of motion. Hemiarthroplasty after failed open reduction and internal fixation is associated with inferior results. We were unable to show a difference in long-term outcome related to the prosthesis type.     

Arthroscopic reconstruction of a complex glenoid rim fracture using suture anchors

The gold standard for the treatment of large displaced glenoid rim fractures has been open reduction and internal fixation using cannulated screws. With the advancement in arthroscopic techniques there has been a growing trend towards arthroscopic treatment of glenoid rim fractures. This report outlines the case of 39-year-old health men who sustained a complex multifragmented displaced glenoid rim fracture after a fall on the right shoulder. The injury was diagnosed by standard radiographs and 3D-CT. An arthroscopic reconstruction including closed reduction and internal fixation using suture anchors was performed. After a follow-up of 1 year the Constant Score was 94 points, the Rowe Score 100 points and the Western Ontario Shoulder Instability Index was 99.9 points. In the Simple Shoulder Test all questions were answered with “yes”. At the latest follow-up the patient was completely painfree and regained a full work activity level. On postoperative 3D-CT imaging the fracture was consolidated in an almost anatomic position with a nearly complete reconstruction of the inferior glenoid circle. In cases of displaced glenoid rim fractures closed reduction and arthroscopic reconstruction using suture anchors can lead to excellent clinical and radiological results.     

Functional rating index: a new valid and reliable instrument to measure the magnitude of clinical change in spinal conditions

STUDY DESIGN: A prospective cohort design was used to evaluate the Functional Rating Index in a multicentered setting with 139 participants. The Functional Rating Index is a self-reporting instrument consisting of 10 items, each with 5 possible responses that express graduating degrees of disability. OBJECTIVES: The goal of this study was to evaluate the psychometric qualities of the Functional Rating Index. SUMMARY OF BACKGROUND DATA: The Functional Rating Index combines the concepts of the Oswestry Low Back Disability Questionnaire and the Neck Disability Index and seeks to improve on clinical utility (time required for administration). METHODS: One hundred thirty-nine subjects with spinal complaints participated in four different cohorts to study reliability, validity, responsiveness, and clinical utility. RESULTS: Reliability: Test-retest: Intraclass correlation coefficient was excellent (ICC3,k = 0.99); interitem correlation: Item efficiency was good, ranging between 0.54 and 0.82, with a moderate correlation among all items; Cronbach's alpha was excellent (0.92). Validity: construct: The Functional Rating Index correlated with the Disability Rating Index (0.76), the Short Form-12 Physical Component Score (0.76), and the Short Form-12 Mental Component Score (0.36). Responsiveness: Overall, the size effect was 1.24, which is commendable. Clinical utility: Time required by the patient and staff averaged 78 seconds per administration, which is noteworthy. Effect of Sociodemographics: Total scores were not affected by education, gender, nor age, suggesting minimal external validity bias. CONCLUSIONS: The Functional Rating Index appears to be psychometrically sound with regard to reliability, validity, and responsiveness and is clearly superior to other instruments with regard to clinical utility. The Functional Rating Index is a promising useful instrument in the assessment of spinal conditions.     

Reliability and validity of the Western Ontario Shoulder Instability Index (WOSI) in the Japanese population

Background  

The Western Ontario Shoulder Instability Index (WOSI) questionnaire is a disease-specific self-evaluated measurement tool used for patients with shoulder instability. The purpose of this study was to evaluate the reliability and validity of the WOSI Japanese version for the Japanese population.     

Patient-reported outcome measures for the knee

In the past 20 years, there has been considerable growth in the number of knee instruments and rating scales designed to measure outcomes from the perspective of the patient. Only a few of these instruments have been evaluated for reliability, validity, and responsiveness. The purpose of this systematic review was to examine the psychometric evidence of patient-reported outcome measures for the knee and identify the best scores for specific knee conditions. A literature search was performed to retrieve references relating to the development and evaluation of knee-specific instruments. Twenty-four unique instruments were identified, and most have satisfactory evidence for internal (alpha > or = 0.82) and test-retest reliability (intraclass correlation coefficient > or = 0.80). Face/content validity was typically assessed during the item selection process, and construct validity was evaluated through strict hypothesis testing or correlations with other clinical measures. For many instruments, effect sizes and standardized response means measuring responsiveness were large (> or = 0.80) within disease-specific populations. Based on the psychometric data, recommendations include the Cincinnati Knee Rating System, Knee Injury and Osteoarthritis Outcome Score (KOOS), and Lysholm Knee Score for anterior cruciate ligament (ACL) injuries, the Kujala Anterior Knee Pain Scale for anterior knee pain, the International Knee Documentation Committee (IKDC) Subjective Knee Form, KOOS, and Lysholm Knee Score for focal chondral defects, the Western Ontario Meniscal Evaluation Tool (WOMET) for meniscal injuries, and the KOOS for osteoarthritis (OA). Although the IKDC can be used as a general knee measure, no instrument is currently universally applicable across the spectrum of knee disorders and patient groups. Clinicians and researchers looking to use a patient-based score for measurement of outcomes must consider the specific patient population in which it has been evaluated. Using a diagnostic algorithm that measures the anatomic parts of the knee as separate constructs may solve this dilemma, allowing for measurement of treatment outcomes across patient groups and selection of the optimal clinical intervention.     

Reliability by surgical status of self-reported outcomes in patients who have shoulder pathologies

STUDY DESIGN: A test-retest design was used to evaluate the reliability of the self-report sections of 4 shoulder pain and disability scales. OBJECTIVE: The objective of the study was to compare interitem consistency and test-retest reliability by surgical status (postoperative versus nonoperative) and to evaluate the effect of surgical status in the prediction of retest scores. BACKGROUND: Patients and healthcare providers evaluate shoulder status based on self-evaluations of pain and disability. Shoulder outcome measures have been developed that include self-reports, but the properties of these measures have not been assessed by surgical status. METHODS AND MEASURES: A questionnaire containing self-report sections of 4 shoulder scales was administered to study participants twice with 1 week between administrations. The outcome measures examined were the: (1) University of California at Los Angeles (UCLA) Shoulder Score; (2) Constant-Murley Scale (CMS); (3) American Shoulder and Elbow Society (ASES) Shoulder Index; and (4) Shoulder Pain and Disability Index (SPADI). Intraclass correlation coefficients (ICC) were calculated to estimate the test-retest reliability of each of the scales and subscales. The interitem consistencies of the multi-item subscales were assessed using Cronbach's alpha. The effect of surgical status on shoulder outcome scale reliability was evaluated using a general linear models approach. RESULTS: The interitem consistency estimates for the multi-item scales were high with both operative and nonoperative participants (0.88 to 0.96). With the exception of the satisfaction subscale of the UCLA Shoulder Score for the nonsurgical group, the estimated intraclass coefficients ranged from 0.51 to 0.91. The prediction of UCLA-satisfaction and ASES-disability, pain, and total retest scores was improved with the addition of surgical status into a regression model. CONCLUSIONS: The examined scales exhibited good internal consistency across surgical status. The postsurgical sample's reproducibility estimates tended to be higher than those of the nonsurgical sample. Reliability of shoulder outcome scales can be affected by patient surgical status.     

Outcome analysis following open rotator cuff repair. Early effectiveness validated using four different shoulder assessment scales

Evaluation of upper extremity function after reconstructive surgery is increasingly important both to predict outcome and for the control of cost-effectiveness. Three validated, self-administered shoulder questionnaires were applied prospectively in 23 otherwise healthy patients with rotator cuff deficiency and correlated to the Constant-Murley Shoulder Score and a visual analogue scale for satisfaction. Seven women and 16 men with combined tears of supraspinatus and infraspinatus (mean age 55.3 ± 10.5 years, r/l: 14/9, follow-up 57.8 ± 15.7 weeks) were gathered prospectively and evaluated pre- and postoperatively with the American Shoulder and Elbow Surgeons (ASES) Shoulder Index, the Simple Shoulder Test (SST) and the Disabilities of the Arm, Shoulder and Hand Module (DASH questionnaire). Additionally, a visual analogue scale for satisfaction was employed. All four scores and the visual analogue scale revealed improvement at a statistically significant level (P < 0.01) after surgery. All questionnaires showed a significant correlation with the Constant-Murley Shoulder Score (ASES: r = 0.871, P < 0.01; DASH: r = –0.758, P < 0.01, SST: r = 0.494, P < 0.05, Pearson’s correlation coefficient). Taken together, all questionnaires were easy to apply, and reliable evaluation of shoulder function was possible with significant correlation to the Constant-Murley Shoulder Score postoperatively. The SST was easy to apply, and compound outcome analysis was possible with the ASES Shoulder Index and DASH questionnaire. The DASH scale was the most complex evaluation instrument. The Constant-Murley Shoulder Score comprises a physical examination, which is advantageous but restricts the application to the office. For postoperative assessment without the patient having to return to the clinic, the ASES Shoulder Index is preferred because of its good correlation to the Constant-Murley Shoulder Score (r = 0.871) and the visual analogue scale for satisfaction (r = 0.762). Received: 4 October 1999     

Critical appraisal of subjective outcome measures used in the assessment of shoulder disability

INTRODUCTION

Objective measures can be impractical in some settings, because they are time consuming and require face-to-face contact. More recently, there is an increasing trend towards the use of subjective outcome measures. Hence, in this article, five common subjective shoulder outcome measures are critically appraised in terms of their development, validity, relia-lity, responsiveness and clinical application.

MATERIALS AND METHODS

Following an extensive literature search, five common shoulder patient-based scores were identified: Disability of Arm, Shoulder and Hand (DASH), Oxford Shoulder Score (OSS), Shoulder Disability Questionnaire (SDQ-UK), Shoulder Pain and Disability Index (SPADI), and the Shoulder Rating Questionnaire (SRQ). These questionnaires were then critically appraised in terms of their development process, validity, reliability, responsiveness, and clinical application.

RESULTS

The SDQ-UK has shown good construct validity but there is no data available regarding internal consistency, reliability and responsiveness. The SPADI has good internal consistency, fair reliability with adequate criterion and construct validity. The DASH has shown to have good construct validity, excellent test–re-test reliability and responsiveness to change. The OSS has good sensitivity, validity and responsiveness. Though SRQ has good internal consistency, its reproducibility and responsiveness are poor.

CONCLUSIONS

Based on this critical appraisal, the DASH received the best ratings for its clinimetric properties followed by the OSS.