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. 2021 May 21;19:187–191. doi: 10.1016/j.jcot.2021.05.018

Measuring outcomes in rotator cuff disorders

Aditya Prinja a,∗, Sanjeeve Sabharwal a, Sebastian Moshtael b, Paola Dey c, Puneet Monga a
PMCID: PMC8178113  PMID: 34141572

Abstract

Measuring the outcome of treatment for rotator cuff disorders has evolved over the last three decades. Objective surgeon-derived outcomes such as clinical examination findings and imaging of the rotator cuff have the limitation of marginalising the patients perception of their condition. Patient reported outcome measures (PROMs) have evolved and become popular in an attempt to demonstrate meaningful outcome data. There are a large number in use today and as a result, the heterogeneity of scores used across the literature can make comparison difficult. Patient reported outcome scores can be general health related quality of life scores, joint-specific and disease specific. Qualitative outcomes are also being used now, and these help us to better understand the context of quantitative research scores. In this article, we provide an overview of the outcome measures used in rotator cuff disorders.

Keywords: Shoulder, Rotator cuff, PROMS, Outcome scores

1. Introduction

To effectively assess and treat orthopaedic conditions relies upon an understanding of the level of disability that the disease process creates. Outcome scores are a valuable tool in this understanding. Traditional outcome measures have been surgeon derived and include range of motion and radiological assessment. These have limitations, particularly because they do not consider how patients perceive their disease or respond to treatment. They also have an inherent bias in clinician assessment.1, 2, 3

Patient reported outcome measures (PROMs) have become more important recently.4 These include general health-related quality of life measurements, health utility evaluations and joint or condition specific measures. These take the patient's perspective and are focused on outcomes that matter more to them rather than the usual clinical indicators that are measured. Typically they will consider the impact on normal activities of daily living and self-care as well as levels of pain and social and emotional function. Measuring PROMs in the UK is routine as part of data collection for the National Joint Registry (NJR).5 Studies have shown that adding a patient perspective to registries gives relevant benefits in terms of quality improvement.6, 7, 8

There are several patient-reported outcome scores currently in use for patients with rotator cuff tears. The Oxford Shoulder Score (OSS), American Shoulder and Elbow Surgeons Standardised Shoulder Form (ASES), Subjective Shoulder Value (SSV), Shoulder Pain and Disability Index (SPADI), and shortened Disability of the Arm, Shoulder and Hand (quickDASH) are all commonly used. Other more generic tools are used to assess the quality of life, including the Short Form 36 (SF-36) and EuroQol-5D (EQ5D) and these are validated for a variety of conditions, including musculoskeletal pathology. There is, however, significant heterogeneity in outcome tools that are used to assess patients with rotator cuff pathology, and, as such, comparison across the studies can be difficult. In this review, we aim to present an overview of the outcome tools used in rotator cuff pathology.

2. History

“Every hospital should follow every patient it treats, long enough to determine whether or not the treatment has been successful, and then to inquire, “if not, why not.“9

The idea of using clinical outcomes in orthopaedic surgery to produce increased benefits to patients was proposed by Ernest Codman in the early 20th century.10 This formed the basis of his concept of the ‘end result.’ He came into the field of surgery at a time when surgeons were the dominant specialists, owing to advances in antisepsis, anaesthesia and innovations in surgical technique. However, unlike many of his colleagues at the time who thought their way to judge surgeons was based on their ‘nerve’ or ‘steady hand,’ he believed that the key to delivering high-quality care was to measure what actually happened to the patients after surgery. He collected his outcomes and described the results in his book ‘A Study of Hospital Efficiency’, but he faced a battle to win over his colleagues and was forced to resign when he tried and failed to implement an end results system at the Massachusetts General Hospital.11 Codman did, however, go on to publish the outcomes of over 300 patients that he had treated.

3. Measuring Outcomes

3.1. Objective clinical outcomes

The objective tools that are used most frequently when assessing response to treatment of rotator cuff disorders are measurement of range of motion, in the outpatient clinic, and magnetic resonance imaging (MRI).

With or without pain, rotator cuff anomalies regularly restrict the range of motion and subsequently have a detrimental effect on the performance of activities of daily living. Range of motion is assessed in routine physical examination both pre and post-intervention for rotator cuff disease and is frequently used as a marker for improvement. However, the complex interplay of glenohumeral and scapulothoracic motion means that clinical assessment of the range of motion may not be helpful as an outcome in rotator cuff disease. Several studies have demonstrated that shoulder range of movement is not strongly correlated with the size or thickness of a rotator cuff tear.12,13 Furthermore, traditional clinical tests are based on the premise that it is possible to isolate individual structures and muscles, but in reality, this is not possible.14 To more accurately assess the range of motion in rotator cuff and other shoulder diseases, motion sensor analysis which can assess scapular and humeral movements, have been shown to be more helpful and can demonstrate the contribution of each of the joints.15

Magnetic resonance imaging (MRI) and ultrasound (US) are both used to evaluate patients after rotator cuff repair. It has been suggested that 25% of patients experience persistent or novel pain after surgical repair, and thus, postoperative imaging of rotator cuff tears is common.16 However, interpretation of the imaging is challenging. Repaired tendons, unlike normal healthy tendons, will demonstrate high signal intensity on MRI, which can be due to pre-existing tendinopathy, postoperative granulation and tissue inflammation rather than re-tear.17 Evidence has suggested that just 10% of asymptomatic patients post rotator cuff repair will have a normal MRI appearance of their tendon.18 Well-functioning patients after surgery may demonstrate thinning for a year after surgery or have a defect from debridement, both of which can be mistaken for a re-tear.17,19 Familiarity with the typical postoperative appearance of the rotator cuff tendons is therefore essential. The dynamic properties of US make this a helpful modality in assessing outcomes after rotator cuff surgery. It has been shown in a meta-analysis to have similar diagnostic accuracy compared to MRI in evaluating the rotator cuff integrity after surgery.20 As with MRI, however, an intact rotator cuff post-surgery may have a varied and abnormal appearance on US, and this can persist for years after surgery.21 Defects have been shown to be present in 20–50% of repaired tendons on US assessment in one study.22 It is imperative, therefore, that any imaging is correlated with clinical assessment when used as an outcome measure after rotator cuff treatment. The drawback of these objective measures therefore, is that they may not necessarily correlate with a patients view of their own improvement.

3.2. Outcome scores

The Oxford Shoulder Score (OSS), when first introduced in 1996, was unique in that it represented patients perspective for the assessment of shoulder surgery, excluding stabilisation surgery.23 It is a twelve item questionnaire designed to evaluate pain and shoulder function. It has become the standard PROM utilised in randomised controlled trials in the United Kingdom as it was designed to be completed by the patient and thus minimises potential reporting bias. As a joint-specific tool, the OSS has been validated and undergone an extensive assessment of reliability.23,24 Unlike many other clinical assessment tools, it can be done remotely, which facilitates ease of data collection and avoids inconvenience and cost. The OSS has been widely translated across the world and also been validated for cross-cultural adaptation in countries in Europe, the Middle East and Asia.25, 26, 27 The OSS was used as the primary outcome measure in a large prospective randomised controlled trial in the UK (UKUFF trial).28 In this study evaluating the clinical and cost-effectiveness of arthroscopic and open rotator cuff repair in patients over the age of 50, the OSS improved significantly in both interventions, and there was found to be no difference between them.

The 30-item disabilities of the arm, shoulder and hand (DASH) questionnaire has also been assessed for reliability, cross-sectional validity and longitudinal validity in numerous conditions of the upper limb.29 It was constructed in 1996 from a collaboration led by the American Academy of Orthopaedic Surgeons (AAOS). The scale assesses multiple domains such as physical function, symptoms and psychosocial factors. It measures shoulder, elbow, hand and wrist function in one metric. This generalisation could be considered a weakness in assessing patients with rotator cuff pathology using this score. Despite this, some studies have shown good correlation and responsiveness comparing the DASH and joint-specific measures.30 From the original DASH, a short version called the QuickDASH, consisting of 11 items from the original 30, was developed.31 This shorter version was thought to be more appealing to patients and researchers alike and has been demonstrated to show similar precision in a validity and reliability study comparing the two.32

In North America, the American Shoulder and Elbow Surgeons Standardised Assessment Form (ASES), published in 1994, is used widely in the published literature.33 It contains a patient self-reported section and another for surgeon reported physical examination findings however, only the pain visual analogue scale and 10 functional questions are typically used to produce the ASES score. It has been shown to be a reliable, valid and responsive outcome tool for various shoulder problems, including rotator cuff disease, and has also been shown to be responsive to nonoperative interventions.34 Like the OSS, the ASES has also been translated, and validity proved worldwide. Criticisms of the ASES score are that the weighting favours the domains of pain and patient-reported function and that in high functioning patients, there may be a ceiling response.35

The Shoulder Pain and Disability Index (SPADI) has 13 items assessing pain (5 items) and disability (8 items). It was first published in 1991 and has had been translated many times with its own validity and reliability.36 Studies have also shown that the SPADI has a very high correlation with changes in active shoulder range of motion and also with DASH score.30,36

Published in 1987, the Constant-Murley Score (CMS or Constant Score) was one of the first outcome measures developed to assess shoulder function and has been one of the most commonly reported outcome scores in Europe.37 Unlike the other scores mentioned in this section so far, the CMS combines physical examination findings of range of motion and strength (worth 65 points) with patient-reported subjective evaluation of shoulder function (worth 35 points). This combination of subjective and objective outcomes had been considered as an advantage, but it is in actual fact likely that reliability is reduced because the two do not necessarily correlate.38,39 However, studies evaluating surgical repair of rotator cuffs have found a good correlation between the CMS and other PROMS.40 Another benefit of the CMS in the context of rotator cuff surgery may be the heavy weighting of on range of motion and strength, but this has been shown to be problematic in instability patients.41,42

The Subjective Shoulder Value (SSV) was described by Gilbart and Gerber in 2007.43 It is defined as the subjective evaluation by a patient of their shoulder function, as a percentage of “normal.” Scores range from zero to one hundred percent. In patients undergoing rotator cuff repair, arthroplasty and instability surgery, the authors found high correlation with the CMS, and performed best for rotator cuff surgery. In view of its ease of use, as a single numerical value that is simple to collect and record, this score has been suggested to be an improvement on many of the other more complicated systems currently in use. There is less evidence for the validity and reliability of the SSV than the other scores mentioned so far and thus its use seems to have been more as an adjunct to other scoring systems, rather than as a stand alone tool.

The Simple Shoulder Test (SST) measures functional limitations of the affected shoulder through 12 questions with yes or no response options.44 For each question, the responder indicates whether they can or can not do a particular activity. This scoring system has been shown to be reliable, but like the SSV, this is less well studied than other scores and thus some of the psychometric properties need to be evaluated further.45 However it is responsive for rotator cuff tears, as patients with proven healed rotator cuff repairs score similarly to healthy controls.46

Another historic score is the University of California Los Angeles (UCLA) shoulder score.47 Like the CMS it is a combination of physical examination findings and subjective, patient reported outcomes including pain, strength and function. The score is weighted towards these subjective outcomes. There are, however, some recognized limitations of this scoring system. Some of the questions are double-barreled and as such patients often have difficulty answering appropriately. And, like the CMS, combining objective and subjective measures into one score does confuse the picture, as we cannot be sure of the correlation. The UCLA score is also less well studied in terms of reliability, validity and responsiveness, as compared to other scores mentioned.

There have been evaluation tools designed specifically to assess patients with pathology of the rotator cuff. Most commonly quoted are the Rotator Cuff Quality of Life Measure (RCQoL) and the Western Ontario Rotator Cuff Index (WORC). Given the widescale use of shoulder specific measures such as those described above, the need for these condition-specific measures has been called into question, particularly as the ceiling effect of general shoulder scoring systems do not seem like an issue for rotator cuff pathology as it does for instability.

3.3. Health utilities

Musculoskeletal conditions are the leading cause of severe long-term pain and disability worldwide, affecting hundreds of millions of people.48 As such, improvement in health-related quality of life (HRQOL) must be a priority target for orthopaedic surgical interventions.49 Rotator cuff pathology is extremely common and causes pain as well as disability, including reduced range of motion and weakness. Several HRQOL tools are available, which play a critical role in assessing the quality of life and general health status in these patients. However, despite the recognized importance of HRQOL after rotator cuff surgery, there are few studies that report them after rotator cuff tear treatment.

Commonly used HRQOL metric include the Short Form Health Survey (SF-36), which has become the most widely used and reliable self-reporting method for assessing health status.50 It has been shown to be reliable, valid and responsive general measure of overall HRQOL in patients with musculoskeletal conditions and shoulder disorders generally.51,52 The questionnaire consists of eight scales producing two summary measures – physical and mental health. A shortened version, the Short Form 12 (SF-12) was introduced later in an attempt to reduce the burden of response.53 This uses the same eight domains as the SF-36. It was shown to have comparable reliability and validity when compared to the SF-36, although standard errors were nearly always larger.53

The EQ-5D, another HRQOL tool, is short and easy to use and shows good responsiveness.54 It was developed in the 1980s by the EuroQol Group to provide a concise, generic way of measuring, comparing and valuing health status. It has two components – a health state description followed by an evaluation. It allows a combination of different dimensions of health to form an overall index, which allows construction of quality-adjusted life years (QALY), a measure that is commonly used in health economic analyses.55 The EQ-5D score is given on a scale of zero to one, where 0 is death, and 1 is full health.

Several studies have reported improvements in patients HRQOL after rotator cuff surgery. Chung et al. showed significant improvement in physical and mental health components of SF-36 in patients undergoing arthroscopic rotator cuff repair.56 Furthermore, they showed a fair to moderate correlation of this with shoulder-specific functional outcomes and also demonstrated that female sex, older age, diabetes and low levels of sporting activity were related to low postoperative HRQOL. Baysal et al. showed improved HRQOL as measured by the Western Ontario Rotator Cuff Index scores after mini-open repair of full-thickness cuff tears.57 Vitale et al. reported increased EQ-5D and Health Utility Index (HUI, another HRQOL tool) in their group of patients treated with arthroscopic rotator cuff repair and showed the improvements were comparable to other interventions, including coronary artery bypass grafting.58

3.4. Qualitative outcomes

Qualitative research involves exploratory analysis that allows researchers to understand complex relationships, patient perceptions and decision-making that quantitative outcomes are often too restrictive to address.59 The methods employed in qualitative research commonly build the themes that form quantitative assessment tools such as patient-reported outcome measures (PROMs).60 Although this type of research has conventionally been overlooked in orthopaedics, it is becoming increasingly common for it to be performed in parallel with randomised controlled trials because it provides a context to their findings, and it allows differences in patient outcomes to be better articulated when making recommendations for change in clinical practice or health policy.61 For rotator cuff disorders, previously published qualitative research is limited, but from the work that has been done, the findings have reinforced the impact of pain and sleep disturbance on the patient experience.62 This research has also demonstrated the psychosocial impact on patients and provided insight into how patients cope with their rotator cuff disease and adapt to their disability.62 Such concepts are essential when discussing disease course and recovery with patients, and it is crucial that future work in the field of rotator cuff disease builds on the limited published qualitative work within this field so that the patients' experience is better understood by clinicians and healthcare professionals managing this group of patients.

4. Discussion

The number of orthopaedic surgical procedures performed is rising worldwide.63 There is, therefore, a challenge for healthcare providers to ensure that with increased uptake, these operations offer good functional outcomes, improved quality of life and the associated costs of additional treatment are justified within the healthcare economy. The World Health Organisation (WHO) has stated that patient centeredness is a fundamental characteristic of quality healthcare provision.64 Moreover, a patient-centred approach can be significantly improved by a collection of disease and joint-specific outcome scores but also global assessments of health reported by patients. It is the view of the authors that it is essential that robust collection of this outcome data becomes routine practice for health care professionals treating rotator cuff tear pathology, alongside the standard objective metrics such as range of motion and relevant radiological assessment.

The collection of objective clinical outcomes, subjective patient-reported outcomes and general health utilities has become standard practice in the treatment of patients with rotator cuff pathology. As we have discussed in this review, there are many different scoring systems used within each of the domains and there is significant heterogeneity in the published literature reporting on outcomes of patients treated. The scoring systems discussed have been validated for shoulder disabilities, including rotator cuff pathology and the general health utilities have also been shown to be relevant in musculoskeletal disease. However, heterogeneity makes comparison across studies difficult. There is no significant body of literature directly comparing outcomes. However, a recent publication has sought to test this. Dabija et al. looked at psychometric properties (reliability, convergent and discriminant validity, and responsiveness) of five commonly used scoring systems (ASES, SPADI, quick DASH, EQ-5D, SF-12) in patients undergoing rotator cuff tear treatment.65 They found that the upper limb scales had acceptable properties. They also demonstrated correlations were high between them and therefore advocated only one upper limb specific tool was needed. Of the three, the SPADI was recommended by the authors to be the best to assess outcomes in patients with rotator cuff tears. An unfortunate limitation of this study was that the authors did not use a wider set of shoulder scores in their comparison, such as the OSS and CMS, which are more commonly used in Europe.

Regarding health utilities, their value in rotator cuff tears has been highlighted in a study by Wylie et al. who looked at the mental health component of the SF-36 in one hundred and sixty-nine patients with full-thickness rotator cuff tears.66 In their study, this score had the strongest correlation with the visual analogue scale for shoulder pain, Simple Shoulder Test (SST) score and ASES ahead of tendon tear morphology (size of tear), BMI, sex, smoking and comorbidities. As discussed earlier, the HRQOL scores have been shown to improve significantly after rotator cuff surgery, and this is of critical importance from a health economic point of view. The spotlight of economic evaluation has never been greater in health policy, and clinicians must be able to demonstrate the health benefits of costly interventions. Appropriate collection of health utility outcome scores is a useful way of doing this.

Outcome score collection does have limitations. Asking patients to fill in large numbers of self-assessment questionnaires in outpatient clinics is time-consuming and likely to have a recall fatigue bias. It is therefore essential to rationalise collection, and further work is required to establish which outcome measure, if any, is the best. A criticism of scoring systems is that they may have floor and ceiling effects, and this has been suggested as an explanation for some studies that have shown no difference between healed and structurally failed rotator cuff repairs. In a study by Jo et al. patients who had undergone rotator cuff repair were evaluated at two years post-op using SST, ASES and UCLA scores.67 The scores showed substantial ceiling effects, and thus the authors suggested caution when interpreting results of studies using these metrics.

As we look to the future, it is clear that the need for healthcare professionals to record and report subjective as well as objective patient-related outcomes will continue to grow and to be expected. Furthermore, consensus opinion on the most reliable PROMs will reduce the heterogeneity across the published literature and allow more meaningful comparison through high-quality meta-analysis. Lastly, the use of technology to collect outcomes should be supported to reduce the burden on patients and providers alike.

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