Shoulder-specific Measures Research Articles

The popularity of outcome measures used in shoulder arthroplasty literature.

Patient-reported outcomes (PROs) are frequently utilized within orthopaedics to determine the extent of patient disease and the efficacy of surgical treatments. Shoulder arthroplasty is a common treatment option for a range of pathologies; however, substantial variety exists regarding the instruments used within the published literature, limiting their quality and generalizability. The purpose of the present systematic review is to evaluate the overall number and frequency of outcome measures used in all clinical studies evaluating outcomes following shoulder arthroplasty. This systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Relevant studies that assessed patient reported outcomes following total shoulder arthroplasty, reverse shoulder arthroplasty, and shoulder hemiarthroplasty were obtained from PubMed, MEDLINE, and EMBASE databases. For each manuscript, the journal, authors, region of origin, level of evidence, and subject/pathology were recorded. The frequency of each reported outcome measure and category. Associations between study characteristics and measure categories were tested using Poisson regression with robust error variance. A total of 682 articles were included in the analysis, reporting 42 different PROs. The most popular tools were the Constant-Murley score (49.7%), the American Shoulder and Elbow Surgeons Evaluation Form (37.7%), and the Visual Analog Scale (34.3%). A generic outcome tool was used in 287 studies (42.1%), while 645 (94.6%) utilized a shoulder-specific measure and 49 (7.2%) used a disease-specific measure. The use of generic (p<0.001) and disease specific (p<0.001) measures were associated with higher level of evidence. Studies assessing patient outcomes following shoulder arthroplasty employ a large range of PRO measuring tools, many of which are non-validated. Furthermore, only a small percentage of studies utilize a combination of tools from different categories despite current recommendations. Consensus on validated and clinically-meaningful tools from multiple categories is necessary to increase the generalizability and applicability of published studies in shoulder arthroplasty literature. 1.

General health measures in shoulder surgery: are we powered for success?

Surgeons, policymakers, and payers increasingly use changes in general health to guide decision-making. It is unknown how such measures are incorporated into shoulder surgery research, how strongly they are associated with changes in shoulder-specific outcomes, and whether they are appropriately powered. PubMed was searched for articles reporting shoulder-specific and general health measures after rotator cuff repair and total shoulder arthroplasty. Study characteristics, results at the study group level, reporting of power calculations, and statistical significance were recorded. Meta-regression was employed to describe the association of changes between shoulder-specific and general health measures. Of 360 identified abstracts, 21 articles with 28 patient groups were included. Only 1 article was published before 2000. There was a strong association of changes between shoulder-specific and general health measures(r = 0.66; P < .001). Power calculations were mentioned in 33% of studies and based on shoulder-specific measures. Of 20 studies conducting hypothesis tests, 75% reported agreement regarding the statistical significance of shoulder-specific and general health tests. Of 5 discordant studies, 4 found the shoulder-specific measure statistically significant and not the general health measure. Shoulder surgery research increasingly reports changes in general health measures that are associated with changes in shoulder-specific measures, suggesting that improvements in shoulder symptoms increase quality of life. When disagreement exists, it usually results from the general health measure's not meeting statisticalsignificance, which may simply reflect type II error. Research reporting general health measures should carefully report power considerations to avoid misinterpretation of findings failing to reach statistical significance.

Rasch analysis indicates that the Simple Shoulder Test is robust, but minor item modifications and attention to gender differences should be considered

Study DesignRepeated cross-sectional study. IntroductionMultiple studies have evaluated the psychometric properties of the Simple Shoulder Test (SST) through traditional methods supporting it as valid and reliable. Since the evidentiary pool supporting the use of the SST has only partially addressed key measurement properties and the development of SST pre-dates the common use of Rasch model, validation of SST has become a necessity to establish as a reliable and valid PRO for shoulder conditions. To date, no study has analysed SST through Rasch, a modern method for analyzing properties of measurement tools. Purpose of the StudyThe purpose of this study was to perform a Rasch analysis of the SST to assess the overall fit to the Rasch model, individual item fit, gender-based DIF, local dependency of items and the unidimensionality of the scale. A secondary purpose was to determine the stability of fit to the Rasch model when captured pre-operatively or post-operatively. MethodologyPatients completed SST before surgery and between 6 months and 1 year after surgery. Rasch analysis was performed to analyse the carious properties of SST through the Rasch model. ResultsSST appears to be robust when tested against the Rasch model. Rasch analysis has highlighted potential areas for to improve in the SST questionnaire. The potential areas to improve are to consider questions that measure the ability of a person to lift the arm above shoulder level and to consider gender differences when measuring the ability to carry weights with the affected arm. DiscussionThis study adds to previous body of empirical evidence arising classical measurement approaches that have suggested that the SST has robust measurement properties, by providing evidence of adequate fit to the Rasch model after minor adjustments. ConclusionThe results of this study should provide confidence to clinicians on SST who wish to use a brief shoulder-specific measure in their practice. The SST appears to be robust when tested against the Rasch model despite some potential areas for improvement. The potential areas that should be explored in future Rasch analyses are the questions that measure the ability of a person to lift the arm above shoulder level and the potential for gender differences when measuring the ability to carry weights with the affected arm.

Psychometric Properties of the Persian Version of the Simple Shoulder Test (SST) Questionnaire.

To validate the Persian version of the simple shoulder test in patients with shoulder joint problems. Following Beaton`s guideline, translation and back translation was conducted. We reached to a consensus on the Persian version of SST. To test the face validity in a pilot study, the Persian SST was administered to 20 individuals with shoulder joint conditions. We enrolled 148 consecutive patients with shoulder problem to fill the Persian SST, shoulder specific measure including Oxford shoulder score (OSS) and two general measures including DASH and SF-36. To measure the test-retest reliability, 42 patients were randomly asked to fill the Persian-SST for the second time after one week. Cronbach's alpha coefficient was used to demonstrate internal consistency over the 12 items of Persian-SST. ICC for the total questionnaire was 0.61 showing good and acceptable test-retest reliability. ICC for individual items ranged from 0.32 to 0.79. The total Cronbach's alpha was 0.84 showing good internal consistency over the 12 items of the Persian-SST. Validity testing showed strong correlation between SST and OSS and DASH. The correlation with OSS was positive while with DASH scores was negative. The correlation was also good to strong with all physical and most mental subscales of the SF-36. Correlation coefficient was higher with DASH and OSS in compare to SF-36. Persian version of SST found to be valid and reliable instrument for shoulder joint pain and function assessment in Iranian population.

Conceptualization and assessment of disability in shoulder-specific measures with reference to the International Classification of Functioning, Disability and Health.

To expand on a previous systematic review of shoulder-specific outcome measures by investigating how concepts of functioning were conceptualized and measured, using International Classification of Functioning, Disability and Health (ICF) constructs as a reference. The material consisted of the linked content of 17 condition-specific measures. The distribution of the key concepts of functioning was assessed in relation to the 3 ICF levels: body level (body functions and structures), personal level (activities) and societal level (participation). Based on this cate-gorization, the concepts were further explored; body functions as to whether they were informed by any contextual information, and activities and participation as to whether they measured a person's capacity, capability or performance. Seven measures assessed all 3 levels of functioning, 8 measured 2 levels, and 2 measured a single level. The majority of the 15 measures including body functions assessed a mix of decontextualized and contextualized functions. Of the 13 measures of activities, 7 measured capabilities, 4 performance and 2 used both constructs. In comparison, among the 11 measures of participation, 5 measured capabilities, 2 performance and 4 a mixture of these. No measure used the capacity construct. Shoulder-specific outcome measures differ in their choice of measurement levels and measurement constructs. The inconsistent use of the capability and performance constructs to measure activities and participation, raise important questions about the suitability of the measures for their intended use.

Impact of Total Shoulder Arthroplasty on Generic and Shoulder-Specific Health-Related Quality-of-Life Measures

Total shoulder arthroplasty is increasingly used in the treatment of arthritis. However, the effect of total shoulder arthroplasty on health-related quality of life has not been fully established. The goal of this systematic review and meta-analysis was to characterize the change in generic and shoulder-specific health-related quality-of-life measures resulting from total shoulder arthroplasty. We identified published studies reporting preoperative and postoperative health-related quality-of-life outcomes for patients receiving total shoulder arthroplasty. Health-related quality-of-life measures were identified, and meta-analysis was used to calculate standardized mean differences (SMDs, reflective of the effect size) and 95% confidence intervals for each scale. Twenty studies (1576 total shoulder replacements) met the inclusion criteria. Outcome measures were analyzed after an average postoperative follow-up duration of 3.7 ± 2.2 years. The Short Form-36 demonstrated significant improvement in physical component summary scores (SMD = 0.7, p < 0.001) but not in mental component summary scores (SMD = 0.2, p = 0.37). Significant improvements were observed in the visual analog scale score for pain (SMD = -2.5, p < 0.001) and scores on three shoulder-specific measures: the Constant score (SMD = 2.7, p < 0.001), American Shoulder and Elbow Surgeons score (SMD = 2.9, p < 0.001), and Simple Shoulder Test (SMD = 2.3, p < 0.001). Total shoulder arthroplasty leads to significant improvements in scores for function and pain. Shoulder-specific measures of function consistently showed the greatest degree of improvement, with large effect sizes. Total shoulder arthroplasty also leads to significant improvements in overall physical well-being, with a moderate-to-large effect size.

The relationship between functional disability and health-related quality of life in patients with a rotator cuff tear

Purpose:To determine the relationship between functional disability and health-related quality of life (HRQoL) in rotator cuff tear (RCT) patients. Method:In 67 RCT patients (mean age, 54 years; 57% males), functional disability was self-reported with the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), HRQoL with the Short-Form 36 Health Survey (SF-36), and pain by visual analogue scale. ASES results were divided into tertiles (12–38, 39–51, and 52–82). Results:Mean ASES score was 48 (range, 12–82). Patients with the highest functional disability and highest pain level had the lowest HRQoL. For the highest, middle, and lowest ASES categories, respectively, mean SF-36 Physical Component Summary (PCS) scores were 35 SD 5, 36 SD 8, and 41 SD 6 (p< 0.001) (r = 0.47 for ASES vs. PCS; p< 0.001), and Mental Component Summary (MCS) scores were 50 SD 13, 56 SD 10, and 58 SD 8 (p = 0.011) (r = 0.37 for ASES vs. MCS; p= 0.003). Conclusions: Patients with higher functional disability had lower HRQoL. RCT extensively affects patients’ lives; therefore, capturing both generic and shoulder-specific measures of RCT problems is recommended.Implications for RehabilitationRotator cuff tears (RCTs) result from injury or degeneration, and tear prevalence increases with age.RCT causes disabling pain, decline in muscle strength and shoulder mobility.RCT patients with decreased functioning have impaired quality of life.

The Simple Shoulder Test Is Responsive in Assessing Change Following Shoulder Arthroplasty

Prospective cohort study with repeated measures. To establish the responsiveness of the Simple Shoulder Test (SST) in comparison to other commonly used clinical outcomes in patients undergoing shoulder arthroplasty. Responsiveness statistics are a useful means to compare different outcomes in terms of their ability to detect clinical change. While the responsiveness of the SST has been established for rotator cuff repair, it has not been determined for patients undergoing arthroplasty. Patients undergoing shoulder arthroplasty (n=120) were evaluated prior to surgery and 6 months after. The evaluation included the SST, Disabilities of the Arm, Shoulder and Hand questionnaire, range of motion, and isometric strength. Responsiveness to change was assessed using standardized response mean (SRM), while longitudinal construct validity was evaluated using Pearson correlation. Receiver operating characteristics curves were plotted to determine clinically important difference of SST. The SST and Disabilities of the Arm, Shoulder and Hand questionnaire were highly responsive (SRM, >1.70) for this population. For the assessment of impairment, range of motion (SRM, 0.64-1.03) was moderately to highly responsive, while isometric strength was minimally to moderately responsive (SRM, 0.32-0.69). The clinically important difference of the SST was established at 3.0 SST points. Pearson correlations indicated moderate associations between the change scores of the SST and the Disabilities of the Arm, Shoulder and Hand questionnaire (r=0.49). The SST has been previously shown to be valid and highly reliable. The present results show that the SST is also responsive following shoulder arthroplasty and that it has a clinically important difference of 3.0 SST points. This should provide confidence to clinicians who wish to use a brief shoulder-specific measure in their practice.

Shoulder-specific disability measures showed acceptable construct validity and responsiveness

Objective To compare the construct validity and responsiveness of the Shoulder Pain and Disability Index (SPADI), Croft Index, and disabilities of the arm, shoulder, and hand (DASH) for patients with adhesive capsulitis and to compare these with pain on a visual analog scale, the Health Assessment Questionnaire, and the problem-elicitation technique. Study Design and Setting Two randomized double-blind placebo-controlled trials of interventions for adhesive capsulitis were performed. Both trials recruited patients from community-based physiotherapy practices. Responsiveness at 3 weeks postbaseline was assessed using four responsiveness parameters and three external criteria for improvement. Results Correlations between the shoulder-specific measures ranged from 0.55 to 0.65 at baseline and 0.49–0.55 for the 3-week change scores. Greater responsiveness was seen for the SPADI. The effect size for the SPADI ranged from 1.20 to 1.64, for the Croft Index from 0.87 to 1.21, and for the DASH from 0.55 to 0.83. Rankings were similar across the four responsiveness parameters and the three external criteria for improvement. Correlations between the shoulder-specific and generic measures for baseline and 3-week change scores were lower than those among the shoulder-specific measures (range: 0.17–0.60). Conclusion The shoulder-specific disability measures showed acceptable construct validity and responsiveness with a small but consistent overall advantage for the SPADI.

Convergent Validity of the Constant-Murley Outcome Measure in Patients with Rotator Cuff Disease

Despite the popularity of the Constant-Murley score (CMS), a combined patient-report and objective (health professional administered) shoulder outcome measure, minimal information exists on its reliability or validity. The purpose of this study was to examine (1) internal consistency and convergent validity of the CMS and (2) the degree to which other shoulder measures explain variation in range of motion and strength components of the CMS. In this cross-sectional study of outcome measures, 45 patients undergoing conservative or surgical treatment for rotator cuff disease participated. Two disease-specific outcome measures, one shoulder-specific measure, and one upper extremity outcome measure were compared to the CMS. Correlations between competing measures and relative total CMS were moderate (0.56 to 0.75). The American Shoulder & Elbow Score, the Upper Extremity Functional Index, the Western Ontario Rotator Cuff Index, and the Rotator Cuff Quality of Life index explained 38%, 28%, 26%, and 10% of variance of the objective component of the CMS respectively. The patient-report component of the CMS measures a multidimensional concept. The strength component had moderate correlations with isometric strength measures of the shoulder external rotators and abductors. The total CMS appears to measure a construct that is not totally captured by competing measures. The unexplained variance may be due, in part, to the lack of importance of the patient's physical impairment to symptoms or activity limitations as measured by other instruments.

A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: protocol implementation and interim performance: lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160

BackgroundThe shoulder is the most frequently dislocated joint in the body. Multiple causes and pathologies account for the various types of shoulder instability. Multi-directional instability (MDI) and multi-directional laxity with antero-inferior instability (MDL-AII) are similar in pathology, less common and more difficult to treat. These instabilities are caused by ligamentous capsular redundancy. When non-operative management fails for these patients, quality of life is significantly impaired and surgical treatment is required to tighten the ligaments and joint capsule. The current reference (gold) standard treatment for MDI/MDL-AII is an open inferior capsular shift (ICS) surgical procedure. An alternative treatment involves arthroscopic thermal shrinkage of redundant capsular tissue to tighten the joint. However, there is a lack of scientific evidence to support the use of this technique called, electrothermal arthroscopic capsulorrhaphy (ETAC). This trial will compare the effectiveness of ETAC to open ICS in patients with MDI and MDL-AII, using patient-based quality of life outcome assessments.MethodsThis study is a multi-centre randomized clinical trial with a calculated sample size of 58 patients (p = 0.05, 80% power). Eligible patients are clinically diagnosed with MDI or MDL-AII and have failed standardized non-operative management. A diagnostic shoulder arthroscopy is performed to confirm eligibility, followed by intra-operative randomization to the ETAC or ICS surgical procedure. The primary outcome is the disease-specific quality of life questionnaire (Western Ontario Shoulder Instability Index), measured at baseline, 3, 6, 12 and 24 months. Secondary outcomes include shoulder-specific measures (American Shoulder and Elbow Surgeons Score and Constant Score). Other outcomes include recurrent instability, complications and operative time.The outcome measurements will be compared on an intention-to-treat basis, using two-sample independent t-tests to assess statistical significance. A Generalized Estimated Equations (GEE) analysis will determine whether there is an effect over time.DiscussionThis ongoing trial has encountered unexpected operational and practical issues, including slow patient enrollment due to high intra-operative exclusion rates. However, the authors have a greater understanding of multi-directional laxity in the shoulder and anticipate the results of this trial will provide the medical community with the best scientific clinical evidence on the efficacy of ETAC compared to open ICS.