Minimal Clinically Important Difference Values Research Articles

Reaching Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient-Acceptable Symptomatic State for Patient-Reported Outcome Measures following Arthroscopic Rotator Cuff Repair Does Not Correlate with Patient Satisfaction.

Purpose: Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) serve as metrics to gauge orthopedic treatment efficacy based on anchoring questions that do not account for a patient's satisfaction with their surgical outcome. This study evaluates if reaching MCID, SCB, or PASS values for American Shoulder and Elbow Surgeons score (ASES), Single Alpha Numeric Evaluation (SANE), Simple Shoulder Test (SST), and Visual Analog Score (VAS) for pain following arthroscopic rotator cuff repair (RCR) correlates with overall patient satisfaction. Methods: This was a single-institution, retrospective study of patients who underwent RCR from 2015 to 2019. Pre-operative and 2 year postoperative ASES, SANE, SST, and VAS scores were recorded. Patients underwent a survey to assess: (1) what is your overall satisfaction with your surgical outcome? (scale 1 to 10); (2) if you could go back in time, would you undergo this operation again? (yes/no); (3) for the same condition, would you recommend this operation to a friend or family member? (yes/no). Spearman correlation coefficients were run to assess relationship between reaching MCID, SCB, or PASS and satisfaction. Results: Ninety-two patients were included. Mean preoperative ASES was 51.1 ± 16.9, SANE was 43.3 ± 20.9, SST was 5.4 ± 2.9, and VAS was 4.6 ± 2.1. Mean 2 year ASES was 83.9 ± 18.5, SANE was 81.7 ± 27.0, SST was 9.8 ± 3.2, and VAS was 1.4 ± 1.9. Mean patient satisfaction was 9.0 ± 1.9; 89 (96.7%) patients would undergo surgery again and recommend surgery. Correlation for reaching PASS for SANE and satisfaction was moderate. Correlation coefficients were very weak for all other outcome metrics. Conclusions: Reaching MCID, SCB, and PASS in ASES, SANE, SST, or VAS following RCR did not correlate with a patient's overall satisfaction or willingness to undergo surgery again or recommend surgery. Further investigation into the statistical credibility and overall clinical value of MCID, SCB, and PASS is necessary.

Determining minimal clinically important differences in the Hammersmith Functional Motor Scale Expanded for untreated spinal muscular atrophy patients: An international study.

Spinal muscular atrophy (SMA) is a rare and progressive neuromuscular disorder with varying severity levels. The aim of the study was to calculate minimal clinically important difference (MCID), minimal detectable change (MDC), and values for the Hammersmith Functional Motor Scale Expanded (HFMSE) in an untreated international SMA cohort. The study employed two distinct methods. MDC was calculated using distribution-based approaches to consider standard error of measurement and effect size change in a population of 321 patients (176 SMA II and 145 SMA III), allowing for stratification based on age and function. MCID was assessed using anchor-based methods (receiver operating characteristic [ROC] curve analysis and standard error) on 76 patients (52 SMA II and 24 SMA III) for whom the 12-month HFMSE could be anchored to a caregiver-reported clinical perception questionnaire. With both approaches, SMA type II and type III patients had different profiles. The MCID, using ROC analysis, identified optimal cutoff points of -2 for type II and -4 for type III patients, whereas using the standard error we found the optimal cutoff points to be 1.5 for improvement and -3.2 for deterioration. Furthermore, distribution-based methods uncovered varying values across age and functional status subgroups within each SMA type. These results emphasize that the interpretation of a single MCID or MDC value obtained in large cohorts with different functional status needs to be made with caution, especially when these may be used to assess possible responses to new therapies.

Minimal clinically important difference in physical activity in patients with stroke

Background Estimates of the minimal clinically important difference (MCID) for stroke-related outcomes are needed, but the MCID for physical activity is unknown. Objective To provide an anchor-based estimate of the MCID for physical activity in patients with stroke. Methods This study included 31 patients with stroke admitted to a hospital and discharged home. Physical activity, including the daily number of steps and metabolic equivalents (METs), was evaluated shortly after informed consent was obtained following admission (baseline) and discharge using an Active-style Pro HJA-750C with a triaxial accelerometer. We calculated the number of steps and time rate (%) of sedentary behavior (SB), light-intensity physical activity (LPA), and moderate-to-vigorous physical activity (MVPA) per day. After discharge, the physical therapist rated each participant’s perceived amount of physical activity recovery on the Global Rating of Change scale (GRC). The mean change in each physical activity data point from baseline to after discharge in the group of participants who answered “a little better, meaningful” in the GRC was considered the MCID. Results Eighteen participants were included in the analysis. Participants’ physical function improved from baseline to at discharge during hospitalization, although mild motor paralysis persisted. MCID values for the step activity, SB, LPA, and MVPA were 1828 steps, -11.2%, 6.9%, 4.3% per day, respectively. Conclusion For researchers and clinicians, this study’s MCIDs provide a benchmark for interpreting changes in the effects of intervention studies, and specific guidelines for interventions in clinical practice. Further research with larger sample sizes is required to confirm these findings.

Patient-reported outcome differences for navigated and robot-assisted total hip arthroplasty frequently do not achieve clinically important differences: a systematic review.

Total hip arthroplasty (THA) using computer-assisted navigation (N-THA) and robot-assisted surgery (RA-THA) has been increasingly adopted to improve implant positioning and offset/leg-length restoration. Whether clinically meaningful differences in patient-reported outcomes (PROMs) compared to conventional THA (C-THA) are achieved with intraoperative technology has not been established. This systematic review aimed to assess whether published relative PROM improvements with technology use in THA achieved minimal clinically important differences (MCIDs). PubMed/MEDLINE/Cochrane Library were systematically reviewed for studies comparing PROMs for primary N-THA or RA-THA with C-THA as the control group. Relative improvement differences between groups were compared to established MCID values. Reported clinical and radiographic differences were assessed. Review of N-THA and RA-THA literature yielded 6 (n = 2580) and 10 (n = 2786) studies, respectively, for analyses. Statistically significant improvements in postoperative PROM scores were reported in 2/6 (33.3%) studies comparing N-THA with C-THA, though only 1 (16.7%) reported clinically significant relative improvements. Statistically significant improvements in postoperative PROMs were reported in 6/10 (60.0%) studies comparing RA-THA and C-THA, though none reported clinically significant relative improvements. Improved radiographic outcomes for N-THA and RA-THA were reported in 83.3% and 70.0% of studies, respectively. Only 1 study reported a significant improvement in revision rates with RA-THA as compared to C-THA. Reported PROM scores in studies comparing N-THA or RA-THA to C-THA often do not achieve clinically significant relative improvements. Future studies reporting PROMs should be interpreted in the context of validated MCID values to accurately establish the clinical impact of intraoperative technology.

Sensitivity to change and responsiveness of provocative load tests among athletes with patellar tendinopathy

BackgroundPain provocation tests are recommended for assessing pain severity and as an outcome measure for individuals with patellar tendinopathy. ObjectiveTo evaluate floor and ceiling effects, sensitivity to change, and responsiveness cut-offs of two provocative load tests among athletes with patellar tendinopathy. MethodsAthletes (N = 41) performed six repetitions for the single leg decline squat (SLDS) and resisted knee extension (KE) at baseline and 12 weeks. Participants rated their pain during each test on a visual analog scale (VAS). Sensitivity to change was assessed by calculating effect size (ES) and the standardized response mean (SRM). The responsiveness cut-offs were assessed using a combination of anchor and distribution- based methods to determine the minimal clinically important difference (MCID) for each test. ResultsA floor or ceiling effect was observed in only a small number of participants for both tests except for KE, for which approximately one third of participants had a floor effect at week 12. There was higher sensitivity to change for SLDS (ES: 1.93/SRM: 1.43) compared with KE (ES:0.96/SRM: 1.09). The MCID corresponded to a decrease of 1.6 points for SLDS and 1.0 for KE, while the distribution-based method estimated 1.2 points for SLDS and 1.1 for KE. ConclusionThis study found moderate to high sensitivity to change and established MCID values for the SLDS and KE test in athletes with patellar tendinopathy before and after rehabilitation. Both tests may be useful as pain on loading outcomes as athletes progress with their rehabilitation, but the KE test results in higher floor effects and has lower sensitivity to change.

Minimal Clinically Important Difference of the Disabilities of the Arm, Shoulder and Hand (DASH) and the Shortened Version of the DASH (QuickDASH) in People with Musculoskeletal Disorders: A Systematic Review and Meta-Analysis.

The objective of this study was to perform a meta-analysis of the minimal clinically important difference (MCID) of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and its shortened version (ie, the QuickDASH). MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, Cochrane Library, and Scopus were searched up to July 2022. Studies on people with upper limb musculoskeletal disorders that calculated the MCID by anchor-based methods were included. Descriptive and quantitative synthesis was used for the MCID and the minimal detectable change with 90% confidence (MDC90). Fixed-effects models and random-effect models were used for the meta-analysis. I2 statistics was computed to assess heterogeneity. The methodological quality of studies was assessed with the Consensus-Based Standards for the Selection of Health Measurement Instruments checklist for measurement error and an adaptation of the checklist for the MCID proposed by Bohannon & Glenney. Twelve studies (1677 patients) were included, producing 17 MCID estimates ranging from 8.3 to 18.0 DASH points and 8.0 to 18.1 QuickDASH points. The pooled MCIDs were 11.00 DASH points (95% CI = 8.59 to 13.41; I2 = 0%) and 11.97 QuickDASH points (95% CI = 9.60 to 14.33; I2 = 0%). The pooled MDC90s were 9.04 DASH points (95% CI = 6.46 to 11.62; I2 = 0%) and 9.03 QuickDASH points (95% CI = 6.36 to 11.71; I2 = 18%). Great heterogeneity was identified among the primary studies along with important methodological problems in the calculation of the MCID. Reasonable MCID ranges of 12 to 14 DASH points and 12 to 15 QuickDASH points were established. The lower boundaries represent the first available measure above the pooled MDC90, and the upper limits represent the upper 95% CI of the pooled MCID. Reasonable ranges for the MCID of 12 to 14 DASH points and 12 to 15 QuickDASH points were proposed. The lower boundaries represent the first available measure above the pooled MDC90, and the upper limits represent the upper 95% CI of the pooled MCID. Information regarding the interpretability of the 2 questionnaires was derived from very different methodologies, making it difficult to identify reliable thresholds. Now clinicians and researchers can rely on more credible data. The MCID proposed should be used to assess people with musculoskeletal disorders. Heterogeneity was found related particularly to the anchor levels used in the primary studies. To promote comparability of MCID values, shared rules defining the most appropriate types of anchoring will be needed in the near future.

Minimial clinically important difference values in distal metaphyseal ulnar shortening for ulnar impaction syndrome and assessment of the relationship between level of the osteotomy and bone union time.

We aimed to define minimal clinically important difference (MCID) values of patient-reported outcome measures (PROMs) for distal metaphyseal ulnar shortening and to assess the relationship between level of the osteotomy and time to bone union. 20 patients who had distal metaphyseal ulnar shortening osteotomies due to ulnar impaction syndrome and had at least 6 months of follow-ups were included in this study. The mean follow-up period was 12.3 ± 7.01 months. The PROMs which consisted of patient-rated wrist evaluation (PRWE) and quick disabilities of arm, shoulder, and hand (QDASH) were recorded on the day before the surgery and at follow-up assessments. Grip strength and range of motion were recorded for operated and contralateral wrists at postoperative assessments. Postoperative radiological evaluations of distance of the osteotomy from the distal ulnar articular surface (osteotomy level), the union of osteotomy site; preoperative and postoperative evaluations of styloid-triquetral distance, and ulnar variance were performed using AP wrist x-rays. The MCID values for PRWE and QDASH were calculated using ROC curve analysis. Mean PRWE and QDASH scores decreased statistically significantly. The mean grip strength of contralateral wrists was higher. Mean ulnar variance decreased, whereas styloid-triquetral distance increased postoperatively. Patients with osteotomy levels of greater than 13.7 mm had a longer time from surgery to bone union. Furthermore, patients with time from surgery to bone union shorter than 7 weeks had an osteotomy closer to the ulnar articular surface. The MCID values for PRWE and QDASH were analyzed and calculated through the ROC curve as 22.25 and 20.45, respectively. This study has shown us that the osteotomy level affects the time to bone union and an osteotomy closer than 13.7 mm to the ulnar articular surface seems to result in shorter union time. Furthermore, MCID values were defined for PRWE and QDASH as 22.25 and 20.45, respectively. Level IV, Therapeutic Study.

Combined, Single-Anchor Subscapularis Tendon Repair and Proximal Biceps Tenodesis Leads to Improved Function and Decreased Pain at 1 Year

PurposeThe purpose of this study was to evaluate the 1-year clinical outcomes of patients treated with combined proximal biceps tenodesis and repair of type II-III subscapularis tendon injuries according to Lafosse et al, using the Loop ‘N’ Tack (LNT) technique. MethodsAll patients undergoing proximal biceps tenodesis and rotator cuff repair (RCR) between March 1st, 2020 and January 30th, 2022 were retrospectively identified. Only patients undergoing combined proximal biceps tenodesis and repair of grade II or III SST injuries with a minimum follow-up of 1 year were included. All patients underwent combined single anchor proximal biceps tenodesis and SST repair using the Loop ‘N’ Tack (LNT) technique. The following outcome scores were recorded at a final follow-up of 1-year postoperatively and were compared to baseline, preoperative values: American Shoulder and Elbow Score (ASES), Single Assessment Numerical Evaluation (SANE), Veterans Rand 12 Item Health Survey (VR-12), and Visual Analog Score (VAS). The minimal clinically important difference (MCID) for all outcome indices was determined with a distribution-based method. ResultsA total of 41 consecutive patients were included. The MCID value for VAS pain, ASES, SANE, and VR-12 mental scores were 0.97, 8.5, 10.9, and 6.0 respectively. At 1-year final follow-up, approximately 95% (39/41) of patients exceeded the MCID for VAS pain scores, 90% (37/41) of patients for ASES scores, 85.4% (34/41) of patients for SANE scores, and 75.6% (31/41) of patients for VR-12 mental health scores. On average, ASES and SANE scores improved by 37 (Pre: 45.2, 1yr: 82.4, p<0.001) and 38 points (Pre: 38.0, 1yr: 75.7, p<0.001) respectively while VAS scores decreased by 4 points (Pre: 5.49, 1yr: 1.48, p<0.001). Approximately 88% (36/41) of patients were satisfied at 1 year post-operatively. Treatment failure was observed in one patient (2.4%). ConclusionPatients treated with combined, single-anchor SST repair and LNT proximal biceps tenodesis achieved significant improvements in function, high satisfaction, and low rates of re-operation at 1 year postoperatively. Additionally, 76% to 95% of patients met the MCID for VAS pain, ASES, SANE, and VR-12 mental health scores. Level of EvidenceLevel IV, retrospective case series

Estimating the minimal clinically important difference of shoulder functional scores after arthroscopic rotator cuff repair: a prospective study

IntroductionThe minimal clinically important difference (MCID) is a valuable tool for patient-based outcome analysis, for which limited data is available in the literature, especially after arthroscopic rotator cuff repair (ARCR). Although several studies have reported MCID after ARCR, few have studied the impact of various clinical factors such as Diabetes, pseudoparalysis, type of cuff repair, and retear over MCID. This study attempts to determine the MCID in shoulder functional scores after ARCR and the impact of various factors on MCID.Methods144 patients undergoing ARCR were prospectively evaluated at six and 12 months by ASES and UCLA scores. MCID for American Shoulder and Elbow Surgeons (ASES) and the University of California and Los Angeles (UCLA) scores were calculated using an anchor-based and distribution-based approach. MCID was also calculated for diabetic and non-diabetic patients, smokers vs. non-smokers, presence or absence of pseudoparalysis, type of cuff repair (single row vs. suture bridge), and presence of retears. Uni- and multivariate analysis was performed to identify factors affecting the MCID of both scores.ResultsMean MCID for ASES score was 13.3 and 16.6 using an anchor-based and distribution-based approach, respectively. For the UCLA score, the mean MCID was 10.0 and 12.6 by anchor-based and 12.6 by distribution-based approach, respectively. Patients with higher pre-operative ASES scores demonstrated lower MCID values. No significant difference was observed in MCID scores of diabetic vs. non-diabetic patients, smoker vs. non-smoker, patients with or without pseudoparalysis, and type of cuff repair. The age, gender, and presence of retear did not affect MCID values.ConclusionThis study establishes the MCID values of ASES and UCLA scores for rotator cuff repair by anchor and distribution methods. No patient or surgical factors appear to affect the MCID except pre-operative ASES scores.Study designProspective cohort, Level II.

Pooled Minimal Clinically Important Differences of the Mini-Balance Evaluation Systems Test in Patients with Early Subacute Stroke: A Multicenter Prospective Observational Study.

Balance problems are common in patients with stroke, and the Mini-Balance Evaluation Systems Test (Mini-BESTest) is a reliable and valid assessment tool for measuring balance function. Determining the minimal clinically important difference (MCID) is crucial for assessing treatment effectiveness. This study aimed to determine the MCID of the Mini-BESTest in patients with early subacute stroke. In this prospective multicenter study, 53 patients with early subacute stroke undergoing rehabilitation in inpatient units were included. The mean age of the patients was 72.6 (SD = 12.2) years. The Mini-BESTest, which consists of 14 items assessing various aspects of balance function, including anticipatory postural adjustments, postural responses, sensory orientation, and dynamic gait, was used as the assessment tool. The global rating of change (GRC) scales completed by the participants and physical therapists were used as external anchors to calculate the MCID. The GRC scale measured subjective improvement in balance function, ranging from -3 (very significantly worse) to +3 (very significantly better), with a GRC score of ≥ + 2 considered as meaningful improvement. Four methods were used to calculate the MCID: mean of participants with GRC of 2, receiver operating characteristic-based method, predictive modeling method, and adjustment of the predictive modeling method based on the rate of improvement. From the MCID values obtained using these methods, a single pooled MCID value was calculated. The MCID values for the Mini-BESTest obtained through the 4 methods ranged from 3.2 to 4.5 points when using the physical therapist's GRC score as the anchor but could not be calculated using the participant's GRC score. The pooled MCID value for the Mini-BESTest was 3.8 (95% CI = 2.9-5.0). The Mini-BESTest MCID obtained in this study is valuable for identifying improvements in balance function among patients with early subacute stroke. Determination of the MCID is valuable for evaluating treatment effectiveness. The study findings provide clinicians with practical values that can assist in interpreting Mini-BESTest results and assessing treatment effectiveness.

Variability of MCID, SCB, and PASS Thresholds in Studies Assessing Patient-Reported Outcomes After Rotator Cuff Repair: A Systematic Review.

An increasing reliance on patient-reported outcomes has led to greater emphasis on minimal clinically important difference (MCID), substantial clinical benefit (SCB), and Patient Acceptable Symptom State (PASS) thresholds in assessing rotator cuff repairs. To review the MCID, SCB, and PASS thresholds reported for patient-reported outcome measures (PROMs) after rotator cuff repair. Systematic review; Level of evidence, 4. The PubMed, Embase, Ovid, Cochrane, and Google Scholar databases were queried for full-text journal articles in English published between January 1, 2000, and May 31, 2022. Studies with MCID, SCB, and PASS thresholds reported for patients with rotator cuff repair and a minimum of 12 months of follow-up were included. Reported MCID, SCB, and PASS thresholds and associated calculation methods were extracted. There were 41 unique studies (6331 shoulders) that met the inclusion criteria. Of these, 37 (90%) reported MCID; 16 (39%), PASS; and 11 (27%), SCB values. The most common PROMs were the American Shoulder and Elbow Surgeons score and the Constant-Murley score. In total, 71% (29/41) of these studies referenced values in the literature, usually studies of patients undergoing rotator cuff repair (21/29). Twelve studies calculated MCID, SCB, or PASS thresholds using anchor-based approaches, whereas 6 studies also calculated thresholds using distribution-based methods. The use of MCID, SCB, and PASS in the rotator cuff repair literature is increasing, with half of the included studies published within the final 17 months of the studied period. Significant variability was seen in the reporting of MCID, SCB, and PASS threshold values after rotator cuff repair. Researchers should prioritize studies that report clinical outcome thresholds calculated using anchor-based methods and should critically review both the anchor question and its response choices. Standardization of MCID, SCB, and PASS values and calculation methods will allow for a more reliable assessment of PROMs in rotator cuff repair moving forward.

Intra-articular corticosteroid injections provide a clinically relevant benefit compared to placebo only at short-term follow-up in patients with knee osteoarthritis: A systematic review and meta-analysis.

To quantify the clinical relevance of intra-articular corticosteroid effects compared to placebo for the injective treatment of knee osteoarthritis (OA). The PubMed, Cochrane Libraryand Web of Science databases were searched on May3, 2023. This study was conducted in accordance with the PRISMA guidelines. The inclusion criteria were randomized controlled trials (RCTs), published in English, with no time limitation regarding publication date, comparing intra-articular corticosteroids and placebo injections for knee OA. The effects were quantified at short- (≤6 weeks), mid- (>6 weeks and ≤3 months), and long-term (≥6 months) follow-ups. The minimal clinically important difference (MCID) for the outcomes (visual analogue scale for pain - VAS: 1.4, Western Ontario and McMaster University Osteoarthritis Index - WOMAC: 9) was used to interpret the clinical improvement provided by intra-articular corticosteroid injections compared to placebo. The quality of each article was assessed using the Cochrane RoB 2 tool and the GRADE guidelines. Among the 1030 articles retrieved, 11 RCTs (842 patients) were included. A comparison of the two groups revealed statistically significant differences in the improvement of VAS and WOMAC scores in terms of the mean difference (MD); this difference was in favour of corticosteroids at short-term (p < 0.001, MD = -1.6 and p < 0.001, MD = -9.9, respectively) and mid-term follow-ups (p = 0.001, mean MD = -1.3 and p = 0.005, MD = -4.9, respectively). No difference was observed at the long-term follow-up. The MDs between the improvements in the two groups reached the MCID values for the VAS and WOMAC only at the short-term follow-up. The RoB 2 tool and the GRADE evaluations showed the presence of risk of bias and limited quality of evidence. This systematic review and meta-analysis demonstrated that intra-articular corticosteroid injections offer clinically perceivable pain relief and functional improvement higher than the placebo effect only at short-term follow-up in patients affected by knee OA, with benefits losing clinical relevance already after 6 weeks. These results, together with the low number and the limited quality of the RCTscomparing this treatment with placebo, question the indication for the use of corticosteroid injections in clinical practice for the treatment of knee OA. Level I.

The MCID of the PROMIS physical function instrument for operatively treated tibial plateau fractures

IntroductionUnderstanding minimal clinically important differences (MCID) in patient reported outcome measurement are important in improving patient care. The purpose of this study was to determine the MCID of Patient-Reported Outcome Measurement System (PROMIS) Physical Function (PF) domain for patients who underwent operative fixation of a tibial plateau fracture. MethodsAll patients with tibial plateau fractures that underwent operative fixation at a single level 1 trauma center were identified by Current Procedural Terminology codes. Patients without PROMIS PF scores or an anchor question at two-time points postoperatively were excluded. Anchor-based and distribution-based MCIDs were calculated. ResultsThe MCID for PROMIS PF scores was 4.85 in the distribution-based method and 3.93 (SD 14.01) in the anchor-based method. There was significantly more improvement in the score from the first postoperative score (<7 weeks) to the second postoperative time (<78 weeks) in the improvement group 10.95 (SD 9.95) compared to the no improvement group 7.02 (SD 9.87) in the anchor-based method (P < 0.001). The percentage of patients achieving MCID at 7 weeks, 3 months, 6 months, and 1 year were 37–42 %, 57–62 %, 80–84 %, and 95–87 %, respectively. DiscussionThis study identified MCID values for PROMIS PF scores in the tibial plateau fracture population. Both MCID scores were similar, resulting in a reliable value for future studies and clinical decision-making. An MCID of 3.93 to 4.85 can be used as a clinical and investigative standard for patients with operative tibial plateau fractures.

Reliability of scapular position and periscapular muscle strength tests in healthy subjects with forward neck and rounded shoulder posture

BACKGROUND: People with forward head posture (FHP) and rounded shoulder posture (RSP) may experience shifts in scapular position and alterations in the strength of the muscles surrounding the scapula. Therefore, a reliable scapula position and scapula muscle strength test are required to identified scapula problem and provided appropriate intervention programs. OBJECTIVE: This study aimed to determine the reliability of scapular position measurements obtained using a modified digital inclinometer and palpation meter, as well as muscle strength using a hand-held dynamometer (HHD) in individuals with FHP and RSP. METHODS: Thirty healthy subjects underwent scapular position tests (upward rotation, anterior tilt, depression, and protraction) and strength tests of periscapular muscles (serratus anterior, upper trapezius, middle trapezius, and lower trapezius) on both the dominant and non-dominant sides. The reliability of the measurements was confirmed by computing the intraclass correlation coefficient (ICC), standard error of measurement (SEM), and minimal clinically important difference (MCID). Test and re-tests were conducted over a period of one week and actual values for each measurement were also obtained and assessed. RESULTS: The ICC ranged from 0.802 to 0.935 for the scapular position tests and from 0.808 to 0.949 for muscle strength tests on the dominant and non-dominant sides. For scapular position tests, SEM values ranged from 0.3 cm to 0.6 cm (protraction and depression), from 1.0∘ to 1.7∘ (upward rotation and anterior tilt) and MCID values ranged from 0.7 cm to 1.6 cm (protraction and depression), from 2.8∘ to 4.7∘ (upward rotation and anterior tilt). Regarding muscle strength tests, SEM and MCID values were in the range 14.4N–27.3N and 39.9N–75.7N, respectively. CONCLUSIONS: Scapular position and periscapular muscle strength can be reproducibly measured in healthy subjects individuals with FHP and RSP. These instruments can hence be recommended for evaluating these functional traits in subjects with FHP and RSP.

Establishing the Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptomatic State After Arthroscopic Posterior Labral Repair for Posterior Glenohumeral Instability

Background: Posterior glenohumeral instability is an increasingly recognized cause of shoulder pain and dysfunction among young, active populations. Outcomes after posterior stabilization procedures are commonly assessed using patient-reported outcome measures including the Single Assessment Numeric Evaluation (SANE), the Rowe instability score, the American Shoulder and Elbow Surgeons (ASES) score, and the visual analog scale (VAS) for pain. The clinical significance thresholds for these measures after arthroscopic posterior labral repair (aPLR), however, remain undefined. Purpose: We aimed to define the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) for the SANE, Rowe score, and ASES score as well as the VAS pain after aPLR. Additionally, we sought to determine preoperative factors predictive of reaching, as well as failing to reach, clinical significance. Study Design: Case-control study; Level of evidence, 3. Methods: This study was a retrospective analysis of patient-reported outcome scores collected from patients who underwent aPLR between January 2011 and December 2018. To determine the clinically significant threshold that corresponded to achieving a meaningful outcome, the MCID, SCB, and PASS were calculated for the SANE, Rowe score, ASES score, and VAS pain utilizing either an anchor- or distribution-based method. Additionally, univariate and multivariate logistic regression analyses were performed to determine the factors associated with achieving, or not achieving, the MCID, SCB, and PASS. Results: A total of 73 patients with a mean follow-up of 82.55 ± 24.20 months were available for final analysis. MCID, SCB, and PASS values for the VAS pain were 1.10, 6, and 3, respectively; for the ASES score were 7.8, 34, and 80, respectively; for the SANE were 10.15, 33, and 85, respectively; and for the Rowe score were 11.3, 60, and 90, respectively. To meet the MCID, male sex (odds ratio [OR], 1.1639; P = .0293) was found to be a positive predictor for the VAS pain, and a lower preoperative SANE score (OR, 0.9939; P = .0003) was found to be a negative predictor for the SANE. Dominant arm involvement was associated with lower odds of achieving the PASS for the ASES score (OR, 0.7834; P = .0259) and VAS pain (OR, 0.7887; P = .0436). Patients who reported a history of shoulder trauma were more likely to reach the PASS for the SANE (OR, 1.3501; P = .0089), Rowe score (OR, 1.3938; P = .0052), and VAS pain (OR, 1.3507; P = .0104) as well as the SCB for the ASES score (OR, 1.2642; P = .0469) and SANE (OR, 1.2554; P = .0444). A higher preoperative VAS pain score was associated with higher odds of achieving the SCB for both the VAS pain (OR, 1.1653; P = .0110) and Rowe score (OR, 1.1282; P = .0175). Lastly, concomitant biceps tenodesis was associated with greater odds of achieving the SCB for the ASES score (OR, 1.3490; P = .0130) and reaching the PASS for the SANE (OR, 1.3825; P = .0038) and Rowe score (OR, 1.4040; P = .0035). Conclusion: To our knowledge, this study is the first to define the MCID, SCB, and PASS for the ASES score, Rowe score, SANE, and VAS pain in patients undergoing aPLR. Furthermore, we found that patients who reported a history of shoulder trauma and those who underwent concomitant biceps tenodesis demonstrated a greater likelihood of achieving clinical significance. Dominant arm involvement was associated with lower odds of achieving clinical significance.

Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptomatic State (PASS) Applied to the SF-36 in Patients Who Underwent Arthroscopic Rotator Cuff Repair.

The 36-Item Short-Form Health Survey questionnaire (SF-36) is a reliable tool to assess the health-related quality of life of patients. If a mean difference between pre-operative evaluation and final follow-up is found to be statistically significant, then the change in score is not random. However, a statistically significant mean change may not correspond to a clinical amelioration for the patient or mean that the patient's state of health is to be considered acceptable. For this reason, interest in the concepts of minimal clinically important difference (MCID) and patient acceptable symptomatic state (PASS) has grown within recent years. The goal of the present work of research was to determine the MCID and PASS values for the SF-36 in patients who received rotator cuff repair (RCR). Forty-six patients (18 women and 28 men, mean age 58.5 ± 12.9) previously diagnosed with rotator cuff disease were enrolled. All of these patients underwent RCR. They were evaluated pre-operatively and six months after the surgical intervention as a final follow-up. The SF-36 questionnaire was assessed at each evaluation. The MCID cut-offs of the total, physical, and mental dimensions of the SF-36 for patients who underwent RCR were 23.1, 32.5, and 18.1, respectively. A 23.1 improvement in the SF-36 score at six months following RCR can be correlated with patients having reached a clinically significant improvement in health status. If 81.9 or more is attained in the SF-36 score after surgical repair, the symptom state can be judged as satisfactory by the majority of patients.

Validation of Minimal Clinically Important Difference (MCID) for University of Pennsylvania Smell Identification Test (UPSIT).

The University of Pennsylvania Smell Identification Test is widely used to measure change in olfactory function, but a minimal clinically important difference (MCID) has not been well-established. A study published in 1997 regarding patients with head trauma reported an MCID of 4 but did not detail the methods used in the calculation. To validate the MCID for UPSIT in patients with postviral, sinusitis, and procedure-associated olfactory loss. This was a secondary analysis of prospectively collected data from 5 clinical research studies related to olfactory function. Three studies included subjects with COVID-19-related olfactory dysfunction, one with chronic sinusitis subjects, and one with subjects undergoing transsphenoidal surgery. All subjects had completed a baseline and follow-up UPSIT, baseline and follow-up Clinical Global Impression-Severity (CGI-Severity), and a follow-up CGI-Improvement. Both distribution- and anchor-based methods were used to determine the MCID of UPSIT. Distribution-based method calculated MCID using half standard deviation of baseline UPSIT and delta UPSIT scores. Clinical-anchor method determined MCID by comparing delta UPSIT scores between consecutive CGI-I clinical categories ranging from very much better to very much worse. The study population comprised 295 subjects. Subjects had a mean (SD) baseline UPSIT score of 27 (7.5), and follow-up score of 28 (7.9), and a mean UPSIT change of 0.6 (5.8). Half the baseline UPSIT SD was 3.75 and half the delta UPSIT SD was 2.9. With the anchor-based approach, an MCID of 4 was defined as clinically meaningful by exploring the relationship between delta UPSIT and CGI-Improvement. Using a more conservative approach based on the MCID values identified from both methods, we determined that a change of 4 or greater is the appropriate MCID for UPSIT. Investigators in the future should use 4 as MCID for UPSIT and report the percentage of study subjects who achieve a clinically meaningful difference. III.

An Evaluation of Patient-reported Outcome Measures and Minimal Clinically Important Difference Usage in Hand Surgery.

This study was designed to examine the current use of patient-reported outcome measures (PROMs) and minimal clinically important difference (MCID) calculations in the hand surgery literature in an effort to standardize their use for research purposes. A systematic review of the hand surgery literature was conducted. All nonshoulder upper extremity articles utilizing PROMs were compared between different journals, different surgical indications, and differing usage. MCID values were reported, and calculation methods assessed. In total, 4677 articles were reviewed, and 410 met the inclusion criteria of containing at least one PROM. Of the 410 articles reporting PROMs, 148 also mentioned an associated MCID. Of the articles that mentioned MCIDs, 14 calculated MCID values based on their specific clinical populations, whereas the remainder referenced prior studies. An estimated 35 different PROMs were reported in the study period; 95 different MCID values were referenced from 65 unique articles. There are many different PROMs currently being used in hand surgery clinical reports. The reported MCIDs from their related PROMs are from multiple different sources and calculated by different methods. The lack of standardization in the hand surgery literature makes interpretation of studies utilizing PROMs difficult. There is a need for a standardized method of calculating MCID values and applying these values to established PROMs for nonshoulder upper extremity conditions.

Achievement of One-Year MCID Varies with Preoperative Function of Patients Undergoing Total Hip Arthroplasty

AbstractThe minimum clinically important difference (MCID) of an orthopaedic outcome measure is commonly used to assess treatment success including for patients undergoing total hip arthroplasty (THA). Various patient factors may contribute to MCID values in patients undergoing THA. The purpose of this study was to calculate the 1-year MCID for the Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) based on patient factors and evaluate if there were any differences between each cohort's MCID.A patient-reported outcome measure (PROM) database was reviewed for patients undergoing THA from 2017 to 2018. Patients were included that underwent primary THA and completed baseline and 1-year follow-up for Patient-Reported Outcome Measurement Information System 10-item global health form (PROMIS10) and HOOS-JR surveys. MCID was calculated using the distribution method and an anchor-based method that used the PROMIS10 Physical Health item. Differences in MCID were assessed between patient cohorts stratified by preoperative characteristics.For the 523 patients that underwent THA, the average 1-year HOOS-JR MCID values were 33.9 ± 16.3 (men), 37.0 ± 13.9 (women), 38.1 ± 17.1 (diagnosis of mental health), and 35.0 ± 14.6 (no diagnosis). MCID values were not significantly different between groups according to sex (p = 0.186) or mental health status (p = 0.302). MCID value did not correlate with body mass index (β = –0.126). MCID achievement had a notable inverse relationship with preoperative HOOS-JR.This study demonstrated that preoperative function of patients undergoing THA affects the ability to achieve HOOS-JR 1-year MCID. Future investigation is necessary to clarify which patient factors may affect MCID.

Preoperative Disability Influences Effectiveness of Minimal Clinically Important Difference and Patient Acceptable Symptom State in Predicting Patient Improvement Following Cervical Spine Surgery.

Retrospective cohort. To compare the characteristics of the minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) metrics when interpreting Neck Disability Index (NDI) following cervical spine surgery. Patients who underwent primary cervical fusion, discectomy, or laminectomy were included. NDI and global rating change (GRC) data at 6months/1year/2years were analyzed. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MCID and PASS in predicting improvement on GRC were calculated for the overall cohort and separately for patients with minimal (NDI <30), moderate (NDI 30 - 49), and severe (NDI ≥ 50) preoperative disability. Two groups with patients who achieved PASS but not MCID and patients who achieved MCID but not PASS were analyzed. 141 patients (206 responses) were included. PASS had significantly greater sensitivity for the overall cohort (85% vs 73% with MCID, P = .02) and patients with minimal disability (96% vs 53% with MCID, P < .001). MCID had greater sensitivity for patients with severe disability (78% vs 57% with PASS, P = .05). Sensitivity was not significantly different for PASS and MCID in patients with moderate preoperative disability (83% vs 92%, P = .1). 17% of patients achieved PASS but not MCID and 9% of patients achieved MCID but not PASS. Most of these patients still reported improvement with no significant difference between the 2 groups (89% vs 72%, P = .13). PASS and MCID are better metrics for patients with minimal and severe preoperative disability, respectively. Both metrics are equally effective for patients with moderate preoperative disability.