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Minimal Clinically Important Differences in ASES and Simple Shoulder Test Scores After Nonoperative Treatment of Rotator Cuff Disease
Robert Z. Tashjian, MD1; Julia Deloach, MS1; Andrew Green, MD2; Christina A. Porucznik, MSPH, PhD3; Amy P. Powell, MD1
1 University of Utah Orthopaedic Center, 590 Wakara Way, Salt Lake City, UT 84108. E-mail address for R.Z. Tashjian: Robert.Tashjian@hsc.utah.edu
2 University Orthopaedics, 2 Dudley Street, Suite 200, Providence RI 02905
3 Department of Family and Preventive Medicine, University of Utah School of Medicine, 375 Chipeta Way, Suite A, Salt Lake City, UT 84108
View Disclosures and Other Information
Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

A commentary by Robin R. Richards, MD, is available at www.jbjs.org/commentary and as supplemental material to the online version of this article.
Investigation performed at the Department of Orthopaedics, University of Utah, Salt Lake City, Utah

Copyright ©2010 American Society for Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2010 Feb 01;92(2):296-303. doi: 10.2106/JBJS.H.01296
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Abstract

Background: 

The minimal clinically important difference is the smallest difference in an outcome score that a patient perceives as beneficial. The purpose of this study was to determine the minimal clinically important difference in the American Shoulder and Elbow Surgeons (ASES) score and in the Simple Shoulder Test (SST) score for patients treated nonoperatively for rotator cuff disease.

Methods: 

Eighty-one patients with tendinitis or a tear of the rotator cuff were treated with nonoperative modalities. Evaluation with the ASES score and the SST was performed at baseline and at a minimum of six weeks after treatment. At the follow-up evaluation, the minimal clinically important difference was estimated for the two scores with use of an anchor-based approach involving fifteen-item (pain and function) and four-item improvement questions.

Results: 

The fifteen-item function and four-item assessments indicated, respectively, that a 2.05-point (p = 0.02) and 2.33-point (p = 0.0009) change in the SST score from baseline represented a minimal clinically important difference. The fifteen-item function, fifteen-item pain, and four-item assessments indicated that a 12.01-point (p = 0.03), 16.92-point (p = 0.004), and 16.72-point (p < 0.0001) change in the ASES score from baseline represented a minimal clinically important difference. Age, sex, initial baseline scores, and hand dominance had no effect on the minimal clinically important differences (p > 0.05). A longer duration of follow-up after treatment was associated with a greater minimal clinically important difference in the ASES score (p < 0.05), although the duration of follow-up had no effect on the minimal clinically important difference in the SST score.

Conclusions: 

Patients with rotator cuff disease who are treated without surgery and have a 2-point change in the SST score or a 12 to 17-point change in the ASES score experience a clinically important change in self-assessed outcome. These minimal clinically important differences can provide the basis for determining if significant differences in outcomes after treatment are clinically relevant.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Robert Z. Tashjian, MD
    Posted on July 31, 2010
    Dr. Tashjian responds to Dr. Toker
    University of Utah Department of Orthopedics, Salt Lake City, Utah

    We appreciate the interest and comments that Dr. Toker has made regarding our manuscript. Dr. Toker raises several important points regarding the conclusions of the article as well as the baseline population we examined to determine MCIDs. We will attempt to address each of these comments.

    Dr. Toker states, “Although the authors stated that the lack of effect might be a reflection of inadequate power, I think that this study has a different place among the other orthopaedic MCID studies by determining the ineffectiveness of the age, sex, initial baseline scores, and hand dominance on MCID. One can think that especially age and sex will have an impact.” While we may be interpreting Dr. Toker’s comment inaccurately, it appears that he is stating that age and sex likely have an impact on MCIDs. We agree with him with regards to this comment. Unfortunately, our study was not able to provide information regarding a positive correlation as we obtained insignificant p-values. We concluded that our study was underpowered with regards to these insignificant findings. We have subsequently performed a power analysis using our data to determine the numbers required in a follow-up study to accurately make these conclusions and we would require a patient population several hundreds larger.

    Dr. Toker also states that these MCIDs are not homogenous enough to be utilized accurately. Unfortunately, a perfectly homogenous population is impossible to define since each individual is slightly different. While we agree with Dr. Toker that our patient population is not completely homogenous, we believe it is homogenous enough to utilize the MCIDs in clinical practice. Up until this study, the only other manuscript that evaluated ASES MCIDs included a population of patients treated for rotator cuff tears, fractures, adhesive capsulitis and postoperative patients (1). While this prior study was homogenous with respect to evaluating patients with shoulder disorders, there was a wide variety of diseases of the shoulder included. Most shoulder surgeons would agree that the clinical expression of rotator cuff disease is very different than that of instability. Similarly, most would agree that the disability of rotator cuff tendonitis can be very similar to patients with partial or full- thickness tears. While we agree that the clinical expression of tendonitis compared to tearing can be different, we believe that tendonitis and tearing are on a spectrum of the disease, and not a completely separate disease, just as patients with arthritis can have mild arthritis or severe arthritis. If we were to take Dr. Toker’s suggestion, then we should potentially have different MCIDs for different tear sizes as massive tears can have a different clinical expression than small or medium sized tears. This concept could be extended to muscle quality, tear retraction, presence or absence of arthritis, etc. It could then be extended to types of non-operative treatment (therapy, injection, ultrasound, TENS) or surgical treatment (single-row repairs, double row- repairs, margin convergence, double-loaded anchors, triple-loaded anchors, etc.). There are so many factors that can potentially affect outcomes that tens to hundreds of MCIDs would need to be determined for the treatment of rotator cuff tears alone. This research task would be very daunting and likely unnecessary as the differences between these different MCIDs would likely be small enough to have a limited effect.

    We believed in the development of the study that the clinical expression of tendonitis and tearing were similar enough that including them in the same population would be reasonable since the population of patients treated in the only other study evaluating ASES MCIDs included several very different shoulder diseases (1). We believe the clinical expression of rotator cuff problems are similar enough, and different enough from other shoulder related disorders like arthritis or instability, that an MCID for rotator cuff disease would be useful and clinically relevant. Similarly, we made the assumption that most non- operative treatments for rotator cuff related problems would probably provide a similar amount of clinical improvement if they were successfully independent of modality. While we believe the further development of other MCIDs is important and necessary, we do believe our data can be generalized to a population of patients treated non-operatively, independent of modality, for rotator cuff tendonitis or tears.

    Reference

    1. Michener LA, McClure PW, Sennett BJ. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, patient self-report section: reliability, validity, and responsiveness. J Shoulder Elbow Surg. 2002;11:587-94.

    Serdar Toker
    Posted on July 07, 2010
    Homogeneous Populations for the Most Correct MCID
    Orthopaedics and Traumatology

    To the Editor:

    I read the article of Tashjian et al. (1) entitled, "Minimal Clinically Important Differences in ASES and Simple Shoulder Test Scores after Nonoperative Treatment of Rotator Cuff Disease", with great interest. Although the authors stated that the lack of effect might be a reflection of inadequate power, I think that this study has a different place among the other orthopaedic MCID studies by determining the ineffectiveness of the age, sex, initial baseline scores, and hand dominance on MCID. One can think that especially age and sex will have an impact. The authors also concluded that the homogeneous nature of their study population improved the ability of the derived MCIDs to be translated into clinical use because they stated that the measures they used were both responsive to change in rotor cuff disease, but I have some concerns about assessing both tendinitis and rotator cuff tear patients together. Is generalizing these two diseases as rotator cuff disease and determining one MCID true? A clinician studying only rotator cuff tear will not be able to use this data to interpret his/her results. In my opinion, studies must be designed to have more homogeneous populations.

    The authors also used different nonoperative treatment modalities and patients received different treatments under the classification of nonoperative treatment. I think that this can also have a negative impact on determining a correct MCID. A clinician who wants to study the efficacy of subacromial corticosteroid injection will not be able to use this data. Hopefully an MCID bank of measures for specific conditions can be established for the use of researchers and clinicians soon.

    The author did not receive any outside funding or grants in support of his research for or preparation of this work. Neither he nor a member of his immediate family received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

    Reference

    1. Tashjian RZ, Deloach J, Green A, Porucznik CA, Powell AP. Minimal clinically important differences in ASES and and simple shoulder test scores after nonoperative treatment of rotator cuff disease. J Bone Joint Surg Am. 2010;92:296-303.

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