title: Responsiveness and Minimal Clinically Important Change: A Comparison Between 2 Shoulder Outcome Measures. Responsiveness of a Danish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial Measurement of health status. Ascertaining the minimal clinically important difference. Arthroscopic surgery for degenerative knee arthritis and meniscal tears: a clinical practice guideline An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand The effects of scapular stabilization based exercise therapy on pain, posture, flexibility and shoulder mobility in patients with shoulder impingement syndrome: a controlled randomized clinical trial Reliability and validity of shoulder function outcome measures in people with a proximal humeral fracture A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group Feeling good rather than feeling better matters more to patients. Acupuncture treatment of shoulder impingement syndrome: A randomized controlled trial. Investigating minimal clinically important difference for Constant score in patients undergoing rotator cuff surgery. Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial Minimal important changes in the Constant-Murley score in patients with subacromial pain.
abstract: Study Design A prospect i ve cohort study nested in a r and omized controlled trial . Objectives To determine and compare responsiveness and minimal clinical ly important change of the  modified Constant score ( CS )  and the  Oxford Shoulder Score ( OSS ) .  Background The OSS and the CS are commonly used to assess shoulder outcomes . However , few studies have evaluated the measurement properties of the OSS and CS in terms of responsiveness and minimal clinical ly important change . Methods The study included 126 patients who reported having difficulty returning to usual activities 8 to 12 weeks after arthroscopic decompression surgery for subacromial impingement syndrome . The assessment at baseline and at 3 months included the  OSS , the CS  , and the  European Quality of Life-5 Dimensions-3 Level ( EQ-5D-3L ) index . Responsiveness was assessed as follows : by correlation analysis between the change scores of the OSS , CS , and EQ-5D-3L index , and the Patient Global Impression of Change ( PGIC ) scale ; by receiver-operating-characteristic ( ROC ) curve analysis using the PGIC scale as an external anchor ; and by effect-size statistics . Results At 3 months , a follow-up assessment of 112 patients ( 89 % ) was conducted . The change scores of the CS and the OSS were more strongly correlated with the external anchor ( PGIC scale ) than the change score of the EQ-5D-3L index . The areas under the ROC curves exceeded 0.80 for both shoulder scores , with no significant differences between them , and comparable effect-size estimates were observed for the CS and the OSS . Minimal clinical ly important change ROC values were 6 points for the OSS and 11 points for the CS , with upper 95 % cutoff limits of 12 and 22 points , respectively . Conclusion The CS and the OSS were both suitable for assessing improvement after decompression surgery INTRODUCTION This prospect i ve cohort study in consecutive shoulder patients sought to determine the minimal , clinical ly important difference of the Danish version of the Disabilities of the Arm , Shoulder and H and ( DASH ) question naire and to evaluate patient responsiveness to it . The study was undertaken at the Outpatient Clinic of the Department of Orthopaedic Surgery , Viborg Regional Hospital , Denmark . MATERIAL AND METHODS During clinical examination , patients completed a baseline question naire including the DASH question naire , the EuroQol-5D index and the EuroQol-VAS .  A follow-up question naire concerning the patient 's global impression of change was posted to the patients eight to nine weeks after the initial assessment . Responsiveness was analysed by correlation analysis and receiver-operating characteristic curve statistics . Using the optimal cut-off point of the receiver-operating characteristic curve , the minimal , clinical ly important difference was determined . RESULTS A total of 81 patients with a variety of shoulder diagnoses were included . Only the DASH question naire demonstrated significant differences in change scores ( p = 0.001 ) . The area under the curve was 0.76 ( 95 % confidence interval 0.62 - 0.90 ) , and a minimal clinical ly important difference of 12 points was found . CONCLUSION The DASH question naire provides a response outcome measure in Danish-speaking orthopaedic shoulder patients . FUNDING This work was supported by the Regional Hospital of Central Jutl and Research Foundation . TRIAL REGISTRATION not relevant Background Subacromial pain syndrome ( SPS ) involving rotator cuff tendinopathy is a common cause of shoulder pain and disability . Evidence suggests that structured physiotherapy may be as effective as surgery in this condition with significant improvements demonstrated in trials involving scapular retraining , rotator cuff strengthening and flexibility exercises . Most published programs typically utilise isotonic concentric and /or eccentric strengthening modes . Recently , immediate analgesic effects and muscle strength gains following heavy-load isometric exercises in lower limb tendinopathy conditions have been observed . It is pertinent to ascertain whether such outcomes can be replicated in SPS/rotator cuff tendinopathy . The primary aim of this study is to establish the feasibility of undertaking a full-scale r and omised controlled trial ( RCT ) that compares the effects of isometric , isotonic concentric and isotonic eccentric rotator cuff contractions when used as part of a semi-st and ardised exercise-based physiotherapy program in patients diagnosed with SPS . The secondary aim is to explore potential trends or treatment effects of the exercise intervention . Methods Thirty-six participants diagnosed with SPS will be r and omised to one of three intervention groups and undergo a one-on-one exercise-based physiotherapy intervention , involving scapular and rotator cuff muscle retraining and strengthening . Each group will utilise a different mode of rotator cuff strengthening — isometric , isotonic concentric or isotonic eccentric . Rotator cuff tendon responses to isometric loading are not yet established in the literature ; hence , individualised , progressive loading will be used in this pilot study in accordance with symptoms . The intervention will involve two phases : during Phase 1 ( weeks 1–6 ) participants undertake the active group-specific physiotherapy treatment ; in Phase 2 ( weeks 6–12 ) , they undertake a progressive , but no longer group-specific exercise program . To determine feasibility , an evaluation of key study parameters including ( a ) ease of recruitment ( rate and number as well as suitability of the assessment algorithm ) , ( b ) adherence to all phases of the exercise intervention including home program compliance and logbook completion , ( c ) participant non-completion ( drop out number and rate ) and ( d ) adverse events ( nature and number ) will be undertaken . Secondary outcomes will measure immediate effects : ( i ) within-treatment changes in pain perception ( verbal rating scale ( VRS ) and shoulder muscle strength ( h and -held dynamometer ) as well as longer-term changes : ( ii ) shoulder-related symptoms and disability ( Western Ontario Rotator Cuff Index ( WORC ) and Shoulder Pain and Disability Index ( SPADI ) ) , ( iii ) perception of pain ( 11-point numerical rating scale ( NRS ) , ( iv ) shoulder muscle strength ( h and -held dynamometer ) and ( v ) perceived global rating of change score . The immediate within-treatment assessment of pain and muscle strength will be undertaken in treatments 2 and 3 , and the longer term measures will be collected at the primary ( conclusion of Phase 1 at 6 weeks ) and secondary ( conclusion of Phase 2 at 12 weeks ) end-points of the study . Discussion The findings of this pilot study will permit evaluation of this study design for a full-scale RCT .Trial registration Australian New Zeal and Clinical Trials Registry , In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials # # # What you need to know What is the role of arthroscopic surgery in degenerative knee disease ? An expert panel produced these recommendations based on a linked systematic review triggered by a r and omised trial published in The BMJ in June 2016 , which found that , among patients with a degenerative medial meniscus tear , knee arthroscopy was no better than exercise therapy . The panel make a strong recommendation against arthroscopy for degenerative knee disease . Box 1 shows all of the articles and evidence linked in this Rapid Recommendation package . The infographic provides an overview of the absolute benefits and harms of arthroscopy in st and ard GRADE format . Table 1 below shows any evidence that has emerged since the publication of this article . Box 1 # # # Linked articles in this BMJ Rapid Recommendations Background The aim of this study was to assess the psychometric properties , namely acceptability , validity , reliability , interpretability and responsiveness of the EuroQol EQ-5D ( EQ-5D visual analogue ( VAS ) and EQ-5D ( utility ) ) , Short Form 12 Dimensions ( SF-12 ) , SF-6D and Michigan H and Outcome Question naire ( MHQ ) in patients with rheumatoid arthritis ( RA ) of the h and . Methods The empirical investigation was based upon data from a r and omised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the h and s and /or wrists . Participants completed the EQ-5D , SF-12 and MHQ at baseline and at 4 and 12 months follow up . Acceptability was measured using completion rates over time ; construct validity using the “ known groups ” approach , based on pain troublesomeness ; convergent validity using spearman ’s rho correlation ( ρ ) ; reliability using internal consistency ( Cronbach ’s alpha ) ; interpretability using minimal important differences ( MID ) ; and responsiveness using effect sizes and st and ardised response means ( SRM ) stratified by level of self-rated improvement in h and and wrist function or level of self-rated benefit and satisfaction from trial treatments . Results At baseline , the study population had a mean age of 62.4 years , a mean MHQ score of 52.1 and included 76 % women . The EQ-5D ( utility ) had the highest completion rates across time points . All instruments discriminated between pre-specified groups based on pain troublesomeness . Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D ( ρ = 0.65 ) and SF-6D ( ρ = 0.63 ) utility scores . The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months , whilst minimal important differences varied considerably across PROMs . Conclusions The instruments evaluated in this study displayed varying psychometric properties in the context of RA of the h and . The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purpose Background : Dysfunction in the kinetic chain caused by poor scapula stabilization can contribute to shoulder injuries and Shoulder Impingement Syndrome ( SIS ) . The purpose of this study was to compare the effectiveness of two treatment approaches scapular stabilization based exercise therapy and physical therapy in patients with SIS . Methods : The study is a r and omized clinical trial in which 68 patients with SIS were r and omly assigned in two groups of exercise therapy ( ET ) and physical therapy ( PT ) and received 18 sessions of treatment . Pain , shoulders ' range of abduction and external rotation , shoulder protraction , scapular rotation and symmetry as well as postural assessment and Pectoralis minor length were evaluated pre and post intervention . The paired- sample t test and the independent sample t test were applied respectively to determine the differences in each group and between two groups . Results : Our findings indicated significant differences in abduction and external rotation range , improvement of forward shoulder translation and increase in the flexibility of the involved shoulder between the two groups ( respectively ; p=0.024 , p=0.001 , p<0/0001 , p<0/0001 ) . No significant difference was detected in pain reduction between the groups ( p=0.576 ) . Protraction of the shoulder ( p<0.0001 ) , forward head posture ( p<0/0001 ) and mid thoracic curvature ( p<0.0001 ) revealed a significant improvement in the ET group . Apparent changes occurred in scapular rotation and symmetry in both groups but no significant differences were observed between the two groups ( respectively ; p=0.183 , p=0.578 ) . Conclusion : The scapular stabilization based exercise intervention was successful in increasing shoulder range , decreasing forward head and shoulder postures and Pectoralis minor flexibility Abstract Purpose : Investigate test -- retest reliability and validity of five shoulder outcome measures in people during their active rehabilitation after a shoulder fracture . Method : This prospect i ve longitudinal study assessed shoulder function in 20 people ( 16 women , mean age 68.1 years ) with surgical or conservative management at 6 , 12 and 13 weeks post proximal humeral fracture using three patient-reported ( Disabilities of Arm , Shoulder and H and ; Oxford Shoulder Score ; Subjective Shoulder Value ) and two clinician-administered ( Constant Score ; UCLA Shoulder score ) outcome measures . Results : Content analysis categorised items into multiple domains of functioning for each outcome measure . Construct validity testing between measures found moderate to strong correlations ( r = 0.43–0.92 ) . Longitudinal validity ( responsiveness ) , represented by correlations between change scores , was moderate to strong ( r = 0.44–0.83 ) . Although ICCs2,1 for test – retest reliability ranged from 0.75 to 0.93 , Limits of Agreement between measurements were relatively wide ( 10–23 % of available range of scores ) . Minimal clinical ly important difference estimates varied between anchor- and distribution-based methods . Conclusions : The five outcome measures assessing shoulder function provided values for reliability and validity that meet measurement requirements for use in groups of people after a proximal humeral fracture . However , the use of these outcome measures might be limited by low absolute agreement between measurements and their content covering multiple domains of functioning . Implication s for Rehabilitation Linking the International Classification of Functioning , Disability and Health ( ICF ) to the content of common shoulder function outcome measures showed that multiple domains of functioning are combined into a single score . This might not be preferred for measurement of the single construct of “ shoulder function ” . Currently available shoulder function outcome measures may not be sufficiently reliable to monitor change in an individual after a proximal humeral fracture during the rehabilitation phase Objective . The Outcome Measures in Rheumatology ( OMERACT ) Shoulder Core Outcome Set Special Interest Group ( SIG ) was established to develop a core outcome set ( COS ) for clinical trials of shoulder disorders . Methods . In preparation for OMERACT 2016 , we systematic ally examined all  outcome domains and measurement instruments reported in 409 r and omized trials of interventions for shoulder disorders published between 1954 and 2015 . Informed by these data , we conducted an international Delphi consensus study including shoulder trial experts , clinicians , and patients to identify key domains that should be included in a shoulder disorder COS . Findings were discussed at a stakeholder premeeting of OMERACT . At OMERACT 2016 , we sought consensus on a preliminary core domain set and input into next steps . Results . There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting , respectively ( 9 attended both meetings ) . Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains : pain , physical function/activity , global perceived effect , and adverse events including death . A middle core consisted of 3 domains : emotional well-being , sleep , and participation ( recreation and work ) . An outer core of research required to inform the final COS was also formulated . Conclusion . Our next steps are to ( 1 ) analyze whether participation ( recreation and work ) should be in the inner core , ( 2 ) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains , and ( 3 ) determine which instruments fulfill the OMERACT criteria for measuring each domain OBJECTIVE To determine the most appropriate means to assess the response to treatment in terms of  pain and functional impairment in a chronic rheumatic condition ( knee osteoarthritis [ OA ] ) and an acute rheumatic condition ( rotator cuff syndrome [ RCS ] ) . METHODS Two prospect i ve studies were conducted consisting of 1,019 out patients with knee OA and 271 patients with acute RCS . The minimal clinical ly important improvement and the patient acceptable symptom state were determined for knee OA pain using a visual analog scale , and for knee OA function using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale ; for acute RCS pain , a numeral rating scale was used , and the Neer function subscale was used for RCS function . RESULTS The minimal clinical ly important improvement was shown to be the change required to achieve the patient acceptable symptom state , whatever the baseline level of symptom , the outcome ( pain or function ) , or type of condition ( chronic or acute ) . This acceptable state for pain was higher for chronic ( 27.0 - 36.4 across the baseline score ) than acute ( 16.7 - 24.1 ) conditions . The level of functional impairment considered satisfactory by patients with knee OA was higher for more disabled patients ( 43.1 ) than for less disabled patients ( 20.4 ) . CONCLUSION Patients consider that they experienced an important improvement only if this improvement allowed them to achieve a state they consider satisfactory . The most appropriate means to assess the response to therapy seems to be to assess whether patients feel good ( i.e. , achieve the patient acceptable symptom state ) BACKGROUND Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice , frequently causing significant functional impairment . The most common cause of shoulder pain is impingement syndrome . OBJECTIVE To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture . METHOD R and omized controlled trial with two groups of participants : one group received true acupuncture ( TA ) and the other received acupuncture at sham points ( SA ) . The treatment was carried out over 4 weeks , with the participants receiving a session every week . The results were measured immediately after the treatment ( T1 ) and 3 months later ( T2 ) . To evaluate the results , we used the 100 mm Visual Analogue Scale ( VAS ) , and to assess the functionality of the shoulder we employed the UCLA question naire ( 0 - 35 points ) . RESULTS A total of 68 participants were included in the analysis ( TA , n=35 ; SA , n=33 ) , with a mean age of 33.4 years ( SD 12.53 ) . We found significant differences in the analyzed results between the two groups , as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 ( CI 95 % 36.7 ; 51.5 ) and 87.58 mm at T2 ( CI 95 % 28.32 ; 46.81 ) , while the decrease in the FA group was of 19.84 mm at T1 ( CI 95 % 12.2 ; 27.4 ) and 20 mm at T2 ( CI 95 % 10.9 ; 29.09 ) . When the UCLA scores were analyzed , the results were clinical ly meaningful in support of TA in terms of functional assessment of the shoulder . No adverse effects were reported . CONCLUSIONS The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinical ly significant results and could be implemented in the therapy options offered by the health services BACKGROUND The minimal clinical ly important difference ( MCID ) is increasingly used to evaluate treatment effectiveness . The MCID for the Constant score has not been previously reported . MATERIAL S AND METHODS A prospect ively collected cohort of 802 consecutive shoulders with arthroscopically treated partial- or full-thickness rotator cuff tears was analyzed . The Constant score was measured preoperatively and at 3 months and 1 year postoperatively . At follow-up visits , the patients were asked a simple 2-stage question : Is the shoulder better or worse after the operation compared with the preoperative state ? This single 2-level question was used as an indicator of patient satisfaction and as an anchor to calculate the  MCID  for the Constant score . RESULTS At 1 year , 781 ( 97.4 % ) patients ( 474 men , 307 women ) were available for follow-up . The preoperative Constant score was 53.1 ( SD 17.2 ) in all patients , 56.2 ( SD 17.4 ) in male patients , and 48.2 ( SD 15.6 ) in female patients . Postoperatively at 3 months , the scores were 61.7 ( SD 16.4 ) in all patients , 65.1 ( SD 16.1 ) in male patients , and 56.8 ( SD 15.5 ) in female patients . At 1 year , the scores were 75.9 ( SD 15.2 ) in all patients , 79.0 ( SD 14.9 ) in male patients , and 71.0 ( SD 14.3 ) in female patients . At 3 months postoperatively , 92.2 % of male patients and 87.2 % of female patients were satisfied with the outcome ( P = .027 ) ; at 1 year , the satisfaction was 93.2 % and 89.5 % , respectively ( P = .067 ) . Five different statistical approaches yielded 5 different MCID estimates ( range , 2 - 16 ) . The 3-month mean change estimate of MCID was 10.4 points . CONCLUSION Our study demonstrates an MCID estimate of 10.4 points as the threshold for the Constant score in patients with rotator cuff tear . LEVEL OF EVIDENCE Basic science study , validation of outcomes instruments/classification systems Abstract Objective To assess the efficacy of arthroscopic subacromial decompression ( ASD )  by comparing it with diagnostic arthroscopy , a placebo surgical intervention , and with a non-operative alternative , exercise therapy , in a more pragmatic setting . Design Multicentre , three group , r and omised , double blind , sham controlled trial . Setting Orthopaedic departments at three public hospitals in Finl and . Participants 210 patients with symptoms consistent with shoulder impingement syndrome , enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015 . Interventions ASD , diagnostic arthroscopy ( placebo control ) , and exercise therapy . Main outcome measures Shoulder pain at rest and on arm activity ( visual analogue scale ( VAS ) from 0 to 100 , with 0 denoting no pain ) , at 24 months . The threshold for minimal clinical ly important difference was set at 15 . Results In the primary intention to treat analysis ( ASD versus diagnostic arthroscopy ) , no clinical ly relevant between group differences were seen in the two primary outcomes at 24 months ( mean change for ASD 36.0 at rest and 55.4 on activity ; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity ) . The observed mean difference between groups ( ASD minus diagnostic arthroscopy ) in pain VAS were −4.6 ( 95 % confidence interval −11.3 to 2.1 ) points ( P=0.18 ) at rest and −9.0 ( −18.1 to 0.2 ) points ( P=0.054 ) on arm activity . No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events . In the secondary comparison ( ASD versus exercise therapy ) , statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest ( −7.5 , −14.0 to −1.0 , points ; P=0.023 ) and VAS on arm activity ( −12.0 , −20.9 to −3.2 , points ; P=0.008 ) , but the mean differences between groups did not exceed the pre-specified minimal clinical ly important difference . Of note , this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group , without comparable exclusions from the exercise therapy group . Conclusions In this controlled trial involving patients with a shoulder impingement syndrome , arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months . Trial registration Clinical trials.gov NCT00428870 OBJECTIVE The purpose of this study was to determine the minimal important change ( MIC ) of improvement in the Constant-Murley score in patients with long-st and ing subacromial pain and in subgroups of patients with subacromial pain with and without rotator cuff ruptures . METHOD The MIC was estimated by the anchor-based MIC distribution method , which integrates an anchor- and distribution-based approach : the optimal cutoff point of the receiver operating characteristic curve ( MICROC ) and the 95 % limit cutoff point ( MIC95 % limit ) . The study population consisted of 93 patients included in a r and omized clinical trial evaluating the effect of a specific exercise strategy .  RESULTS The MICROC was found at a mean change of 17 points in the Constant-Murley score , which corresponds to a sensitivity of 91 % and a specificity of 79 % . The MIC95 % limit was found at a mean change of 24 points . In the subgroup analysis , the MICROC was found at a mean change of 19 points and the MIC95 % limit at 18 points in patients with an intact rotator cuff . In patients with rotator cuff ruptures , the MICROC was found at a mean change of 15 points and the MIC95 % limit at 30 points . CONCLUSION The Constant-Murley score is able to detect the MIC in individual patients with long-st and ing subacromial pain when the rotator cuff is intact . The estimated MIC values could be used as an indication for relevant changes in the Constant-Murley score in clinical practice and guide the clinician in how to interpret the results of specific treatments
target: Our review provides anchor-based MID estimates , as well as a rating of their credibility , for PROMs for patients with shoulder conditions .
  The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain , and could also prove useful for authors addressing other interventions for shoulder problems .
background: OBJECTIVES To identify credible anchor-based minimal important differences ( MIDs ) for  patient-reported outcome measures  ( PROMs ) relevant to a BMJ Rapid Recommendations addressing subacromial decompression surgery for shoulder pain .