Substantial Clinical Benefit Values Research Articles

Reaching MCID, SCB, and PASS for ASES, SANE, SST, and VAS following shoulder arthroplasty does not correlate with patient satisfaction

BackgroundMinimally clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) have been established in the literature to gauge shoulder arthroplasty treatment effectiveness. These metrics are established 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 (ASES), Single Assessment Numeric Evaluation (SANE), Simple Shoulder Test (SST), and visual analog scale (VAS) at 2 years following shoulder arthroplasty correlates with overall patient satisfaction. MethodsThis was a single-institution, retrospective, cohort study of all patients who underwent shoulder replacement from 2015 to 2019. Preoperative and 2-year postoperative ASES, SANE, SST, and VAS scores were recorded. Previously established MCID, SCB, and PASS values were used. Patients were contacted and underwent a survey to assess: (1) on a scale of 1 to 10, what is your overall satisfaction with your surgical outcome? (2) if you could go back in time, would you undergo this operation again? (yes/no); and (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 the relationship between reaching MCID, SCB, or PASS and the 3 outcome metrics above. ResultsThree hundred fifty two patients were included. Mean preoperative ASES was 42.2 ± 16.4, SANE was 35.5 ± 18.9, SST was 4.5 ± 2.6, and VAS was 5.3 ± 2.4. Mean 2-year ASES was 87.8 ± 16.0, SANE was 87.1 ± 15.7, SST was 9.8 ± 2.4, and VAS was 0.9 ± 1.8. Mean patient satisfaction was 9.0 ± 2.0, 331 (94.0%) patients would undergo surgery again, and 330 (93.8%) patients would recommend surgery. Spearman correlation coefficients were weak or very weak for reaching MCID, SCB, and PASS in ASES, SANE, SST, and VAS and all 3 study outcome metrics. DiscussionPatient overall satisfaction is one of many considerations when indicating a patient for shoulder replacement and evaluating their ultimate long-term outcome. Reaching MCID, SCB, and PASS in ASES, SANE, SST, and VAS following shoulder arthroplasty did not correlate with a patient’s overall satisfaction, willingness to undergo surgery again, or willingness to recommend surgery to a friend or family member. Further investigation into the reliability and clinical value of currently defined MCID, SCB, and PASS metrics is needed.

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.

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

Background: 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. Purpose: To review the MCID, SCB, and PASS thresholds reported for patient-reported outcome measures (PROMs) after rotator cuff repair. Study Design: Systematic review; Level of evidence, 4. Methods: 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. Results: 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. Conclusion: 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.

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.

Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB), and Patient Acceptable Symptom State (PASS) of the Shoulder Disability Questionnaire (SDQ) in Patients Undergoing Rotator Cuff Repair.

The Shoulder Disability Questionnaire (SDQ) is a Patient-Reported Outcome Measure (PROM) applied to evaluate shoulder surgery outcomes. The purpose of this study is to identify the accurate Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB) and Patient Acceptable Symptom State (PASS) values for the SDQ score. A total of 35 patients (21 women and 16 men, mean age 76.6 ± 3.2 years) were followed up at 6 months postoperatively. To assess the patient's health satisfaction and symptoms, anchor questions were used. The MCID and SCB values of the SDQ score for patients who underwent arthroscopic rotator cuff repair from inception to final follow-up were 40.8 and 55.6, respectively. A change of 40.8 in the SDQ score at 6 months after surgery shows that patients achieved a minimum clinically important improvement in their state of health, and a 55.6 change in the SDQ score reflects a substantial clinically important improvement. The PASS cut-off of the SDQ score at 6 months postoperatively ranged from 22.5 to 25.8. If an SDQ score of 22.5 or more is attained after surgery, the health condition can be recognized as acceptable by the majority of patients. These cut-offs will help with understanding specific patient results and allow clinicians to personally assess patient improvement after rotator cuff repair.

Comparison of the PROMIS and iHOT-12 in Determining Satisfaction Levels After Hip Arthroscopy for FAIS.

The Patient-Reported Outcomes Measurement Information System (PROMIS) has not been fully evaluated for outcomes assessment after hip arthroscopy to correct femoroacetabular impingement syndrome (FAIS). The purpose of this study was to compare the accuracy of the PROMIS Physical Function (PF) and Pain Interference (PI) subscales with the 12-Item International Hip Outcome Tool (iHOT-12) to define patients with 3 unique substantial clinical benefit (SCB) scores-patients who reported ≥80%, ≥90%, and 100% satisfaction at 1 year after hip arthroscopy for FAIS. We hypothesized that the iHOT-12 would be more accurate than the PROMIS-PF and PROMIS-PI subscales in identifying these 3 patient groups. Cohort study (diagnosis); Level of evidence, 2. We reviewed the records of patients who underwent hip arthroscopy for symptomatic FAIS at 3 centers from January 2019 through June 2021 and had 1-year clinical and radiographic follow-up data. Patients completed the iHOT-12, PROMIS-PF, and PROMIS-PI on initial assessment and at 1 year (±30 days) postoperatively. Postoperative satisfaction was reported on an 11-category scale with anchors defined as "0% satisfied" and "100% satisfied." Receiver operator characteristic analysis was performed to determine the absolute SCB values for the iHOT-12 and PROMIS subscales that would most accurately identify those patients who reported ≥80%, ≥90%, and 100% satisfaction. Area under the curve (AUC) values and 95% CIs for the 3 instruments were compared. Included were 163 patients (111 [68%] women and 52 [32%] men), with a mean age of 26.1 years. Corresponding absolute SCB scores for patients who reported ≥80%, ≥90%, and 100% satisfaction were as follows: iHOT-12, 68.4, 72.1, 74.7; PROMIS-PF, 45, 47.7, 49.9; and PROMIS-PI, 55.9, 52.4, 51.9. The AUC ranged between 0.67 and 0.82, with overlapping 95% CIs indicating a minimal difference in accuracy between the 3 instruments. Sensitivity and specificity values ranged between 0.61 and 0.82. The PROMIS-PF and PROMIS-PI subscales were as accurate as the iHOT-12 in defining absolute SCB scores for patients reporting ≥80%, ≥90%, and 100% satisfaction at 1-year follow-up after hip arthroscopy for FAIS.

Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) of upper extremity PROMIS scores following arthroscopic rotator cuff repairs.

To calculate and determine what factors are associated with achieving the Minimal Clinically Important Difference (MCID) and the Substantial Clinical Benefit (SCB) of Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Testing v2.0 (UE), Pain Interference (P-Interference), and Pain Intensity (P-Intensity) in patients undergoing arthroscopic rotator cuff repair (aRCR). The change in PROMIS scores representing the optimal cutoff for a ROC curve with an area under the curve analysis was used to calculate the anchor-based MCID and SCB. To assess the responsiveness of each PROM, effect sizes and standardized response means (SRM) were calculated. To identify factors associated with attaining the MCID and SCB, univariate and multivariate logistic regression analyses were performed. A total of 323 patients with an average age of 59.9 ± 9.5 were enrolled in this study, of which, 187/323 [57.9%] were male and 136/323 [42.1%] were female. The anchor-based MCID for PROMIS UE, P-Interference, and P-Intensity was: 9.0, 7.5, and 11.2, respectively. The respective SCB was 10.9, 9.3, and 12.7. Effect size and SRM were: PROMIS UE (1.4, 1.3), P-Interference (1.8, 1.5), and P-Intensity (2.3, 2.0). Lower preoperative P-Intensity scores (p = 0.02), dominant arm involvement (p = 0.03), and concomitant biceps tenodesis (p = 0.03) were associated with patients achieving the SCB for PROMIS UE. A large responsiveness for each of the PROMIS instruments due to the majority of patients reporting great improvement after aRCR and a small standard deviation across all outcome measures was shown in our study. Lower preoperative P-Intensity scores and concomitant biceps tenodesis were associated with higher odds of achieving the SCB for PROMIS UE. The knowledge of MCID and SCB values for PROMIS instruments will allow the surgeon to determine whether the improvements in the PROMIS scores after aRCR are clinically meaningful. Level III.

Substantial clinical benefit values demonstrate a high degree of variability when stratified by time and geographic region.

A Substantial Clinical Benefit (SCB) value is the amount of change in a patient-reported outcome measure required for a patient to feel they significantly improved from an intervention. Previously published SCB values are often cited by researchers when publishing outcomes data. Where these SCB values are set can have a large impact on the conclusions drawn from a study citing them. As such, the goal of this study was to determine the generalizability of SCB values for a procedure when stratified by time from surgery and geographic region. A nationwide outcomes database was utilized to obtain preoperative, one-year, and two-year postoperative outcome measurements for patients who underwent anatomic total shoulder arthroplasty (TSA) or reverse TSA. The data were divided into three geographic regions: the South, the Midwest, and the West. An East region was not included due to its limited number of patients. SCB values were calculated for four outcomes measures: Single Assessment Numeric Evaluation score, American Shoulder Elbow Surgeons score, Visual Analog Scale, and Western Ontario Osteoarthritis of the Shoulder score. SCB values were calculated for each region, for each procedure, and at both one and two years postoperatively. To determine the variability of potential SCBs within each region, simulated datasets were created to determine a distribution of possible calculated SCBs. A total of 380 anatomic TSA patients and 543 reverse TSA patients were included for analysis. There was a high degree of variability of SCB values when stratified by procedure, time, and region. While some simulated datasets did produce homogenous SCB distributions among regions, some outcome measures demonstrated a large heterogeneity in distribution among regions, with concomitant large distributions of values within individual regions. There is notable heterogeneity of SCB values when stratified by region or time. The current method of citing previously published SCB values for determining the efficacy of an intervention may be inappropriate. It is likely that this variability holds true in other areas of orthopedics.

Patient Acceptable Symptom State, Minimal Clinically Important Difference, and Substantial Clinical Benefit After Arthroscopic Superior Capsular Reconstruction

Background: Patient Acceptable Symptom State (PASS), minimal clinically important difference (MCID), and substantial clinical benefit (SCB) have rarely been assessed after arthroscopic superior capsular reconstruction (ASCR) with fascia lata autograft. Purpose: (1) To investigate PASS, MCID, and SCB values for pain visual analog scale (pVAS), American Shoulder and Elbow Surgeons (ASES) score, Constant score, and Single Assessment Numeric Evaluation (SANE) after ASCR with fascia lata autograft, (2) to investigate factors for achieving PASS, MCID, and SCB. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: We retrospectively collected data from patients who underwent ASCR between June 2013 and October 2020. A total of 88 patients were included, and anchor questions for deriving PASS, MCID, and SCB values were applied at a minimum 1-year follow-up postoperatively. PASS, MCID, and SCB were derived using sensitivity- and specificity-based approaches. Univariable and multivariable logistic regression analyses were performed to determine factors for achieving PASS, MCID, and SCB. Results: Based on receiver operating characteristic curves, all 4 scores had acceptable area under the curve values (>0.7) for PASS, MCID, and SCB values. The PASS, MCID, and SCB values were 1.5, 2.5, and 4.5 for pVAS; 81.0, 19.0, and 27.5 for the ASES score; 60.5, −0.5, and 5.5 for the Constant score; and 75.0, 27.5, and 32.5 for SANE, respectively. Poor preoperative scores were related to significantly higher odds ratios (ORs) for achieving MCID and SCB. Wide acromiohumeral distance and dominant side were related to higher ORs for achieving PASS for the ASES score, and subscapularis tear was related to lower ORs for achieving PASS for pVAS and SCB for the Constant score. Conclusion: Reliable PASS, MCID, and SCB values were achieved for at least 1 year after ASCR surgery. Poor preoperative score, wide acromiohumeral distance, and dominant side all demonstrated higher ORs for at least one value, but a subscapularis tear demonstrated lower ORs for achieving PASS for pVAS and SCB for the Constant score.

Establishing the Minimal Clinically Important Difference and Substantial Clinical Benefit for the Pain Visual Analog Scale in a Postoperative Hand Surgery Population

Although the pain visual analog scale (VAS-pain) is a ubiquitous patient-reported outcome instrument, it remains unclear how to interpret changes or differences in scores. Therefore, our purpose was to calculate the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) for the VAS-pain instrument in a nonshoulder hand and upper extremity postoperative population. Adult postoperative patients treated by 1 of 5 fellowship-trained orthopedic hand surgeons at a single tertiary academic medical center were identified. Inclusion required VAS-pain scores at baseline (up to 3 months before surgery) and follow-up (up to 4 months after surgery), in addition to a response to a pain-specific anchor question at follow-up. The MCID estimates were calculated with (1) the 1/2 standard deviation method; and (2) an anchor-based approach. The SCB estimates were calculated with (1) an anchor-based approach; and (2) a receiver operator curve method that maximized the sensitivity and specificity for detecting a "much improved" pain status. There were 667 and 148 total patients included in the MCID and SCB analyses, respectively. The 1/2 standard deviation MCID estimate was 1.6, and the anchor-based estimate was 1.9. The anchor-based SCB estimate was 2.2. The receiver operator curve analysis yielded an SCB estimate of 2.6, with an area under the curve of 0.72, consistent with acceptable discrimination. We propose MCID values in the range of 1.6 to 1.9 and SCB values in the range of 2.2 to 2.6 for the VAS-pain instrument in a nonshoulder hand and upper extremity postoperative population. These MCID and SCB estimates may be useful for powering clinical studies and when interpreting VAS-pain score changes or differences reported in the hand surgery literature. These values are to be applied at a population level, and should not be applied to assess the improvement, or lack thereof, for individual patients.

The substantial clinical benefit of comprehensively considering low back pain and radiating pain caused by lumbar intervertebral disc herniation.

Patients with lumbar disc herniation (LDH) may experience low back pain (LBP) and radiating pain (RP). Currently, there is no substantial clinical benefit (SCB) of assessing both LBP and RP due to LDH. To determine enhanced SCB values by simultaneously assessing LBP and RP. We retrospectively evaluated hospitalized LDH patients with concomitant LBP and RP between June 1, 2012, and May 31, 2013, and determined the numeric rating scale (NRS) and Oswestry Disability Index (ODI) scores at admission and discharge. Furthermore, the area under the receiver operating characteristic curve (AUC) was computed to assess diagnostic accuracy. SCB as per NRS for both LBP and RP was -2.50 in the 186 enrolled patients (AUC: 0.699 and 0.704, respectively). SCB as per ODI was -18.78 (AUC: 0.771). SCB for the mean of the two NRS scores for LBP and RP was -2.75 (AUC: 0.757). SCB for NRS score with a larger change in LBP and RP was -3.50 (AUC: 0.767). SCB may be determined by comprehensively considering LBP and RP and choosing the mean NRS or NRS score with a large change.

Establishing the Substantial Clinical Benefit in a Non-Shoulder Hand and Upper Extremity Population for the QuickDASH and PROMIS Upper Extremity and Physical Function Computer Adaptive Tests

It is unclear what score changes on the abbreviated Disabilities of the Arm, Hand, and Shoulder (QuickDASH), Patient-Reported Outcomes Measurement Information System (PROMIS) upper extremity (UE) computer adaptive test (CAT), and PROMIS physical function (PF) CAT represent a substantial improvement. We calculated the substantial clinical benefit (SCB) for these 3 instruments in a non-shoulder hand and upper extremity population. Adult patients treated between March 2015 and September 2019 at a single academic tertiary institution were identified. The QuickDASH, PROMIS UE CAT v2.0, and PROMIS PF CAT v2.0 scores were collected using a tablet computer. Responses to the QuickDASH both at baseline and follow-up 6 ± 4 weeks later, and a response to the anchor question "Compared to your first evaluation at the University Orthopaedic Center, how would you describe your physical function level now?" were required for inclusion. A second anchor question querying treatment-related improvement was also used. The SCB was calculated using an anchor-based approach comparing the mean change difference between groups reporting no change and a maximal change for both anchor questions. Of 1,119 included participants, the mean age was 48 ± 17 years, 53% were women, and half were recovering from surgery. Score changes between baseline and follow-up were significantly different between groups reporting no improvement and maximal improvement on both anchor questions. The SCB values ranged between 16.9 and 22.8 on the QuickDASH, 5.9 and 7.1 on the UE CAT, and 3.5 and 6.7 on the PF CAT. These score improvements for the QuickDASH, UE CAT, and PF CAT represent a substantial clinical improvement in a non-shoulder hand and upper extremity population. These SCB estimates may assist with the interpretation of outcome scores at a population level.

The Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient-Acceptable Symptomatic State after Medial Patellofemoral Ligament Reconstruction

PurposeTo define the minimal clinically important difference (MCID), substantial clinical benefit (SCB) and patient-acceptable symptomatic state (PASS) for patient-reported outcome measures (PROMs) after medial patellofemoral ligament reconstruction (MPFLR) and to investigate the role of preoperative, demographic, and intraoperative variables for predicting achievement of these thresholds.MethodsThis retrospective cohort study used a prospectively maintained database of patients undergoing primary MPFLR between August 2015 and December 2019. PROMs included the International Knee Documentation Committee (IKDC), Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS joint replacement (JR), and Kujala. Anchor-based and distribution-based methods were used to calculate the MCID, SCB, and PASS. Regression analyses were performed to identify prognosticators for achievement of clinically significant thresholds.Results139 patients met inclusion criteria (mean age: 21.7± 8.2 years). At 6 months, the MCID values were 8.3 (KOOS-Pain) and 8.5/13.5 (Kujala); SCB values were 1.4 (KOOS-Pain) and 43.7 (KOOS-QOL); and PASS values were 64.9 (IKDC), 83.3 (KOOS-Symptom), 76.8 (KOOS-Pain), 91.2 (KOOS-ADL), 47.5 (KOOS-Sport), 40.6 (KOOS-QOL), and 78.1 (KOOS-JR). At 1 year, the MCID values were 4.2 (KOOS-Pain), 7.2 (KOOS-ADL), 12.4 (KOOS-QOL) and 25.2 (KOOS-JR); SCB were 23.6 (IKDC), 4.2 (KOOS-Symptom), 19.7 (KOOS-Pain), 6.5 (KOOS-ADL), 55.0 (KOOS-Sport), 6.3 (KOOS-QOL), and 19.6/25.2 (KOOS-JR); and PASS were 65.5 (IKDC), 80.4 (KOOS-Symptom), 84.7 (KOOS-Pain), 99.3 (KOOS-ADL), 57.5 (KOOS-Sport), 53.1 (KOOS-QOL), and 76.3 (KOOS-JR). In regression analysis, greater age, body mass index, and preoperative PROMs were negative prognosticators for achieving clinically significant thresholds. Conversely, male gender increased the likelihood of achieving PASS for Kujala at 6 months and KOOS-ADL at 1 year.ConclusionsThis study established thresholds for the MCID, SCB, and PASS at 6 months and 1 year after MPFLR, providing physicians an evidence-based method to advise patients and assess outcomes with this surgery. Older patients and those with higher preoperative outcome scores are less likely to report improvement and satisfaction with MPFLR, while male patients are more likely to report some satisfaction.Level of EvidenceLevel III, retrospective cohort study (diagnosis).

Vascular Quality of Life Questionnaire-6 Before and After Supervised Exercise Therapy in Patients with Intermittent Claudication

The Vascular Quality of Life Questionnaire-6 (VascuQoL-6) is a short, disease specific instrument used to determine health related quality of life (HRQoL) in patients with peripheral arterial disease. This study aimed to assess the minimally important difference (MID) and substantial clinical benefit (SCB) of the VascuQoL-6 in Dutch patients with intermittent claudication (IC) receiving supervised exercise therapy (SET). Consecutive patients with IC who were recruited from a single centre between January 2016 and December 2016 completed the VascuQoL-6 before initiation and after three months of SET. They subsequently answered an anchor question rating their current health status as much improved, improved, unchanged, deteriorated, or much deteriorated, compared with baseline. The MID for improvement and deterioration and SCB were calculated using anchor based and distribution based methods. A total of 124 patients with IC (58% male, mean age 68 years) completed the study protocol. Baseline VascuQoL-6 scores increased from 16.3 ± 4.4 to 18.7 ± 3.8 after three months of SET (p < .001). MID values ranged from+2.0 to+3.8 points regarding HRQoL improvement and from+0.2 to -2.2 points regarding HRQoL deterioration. The SCB ranged from+3.7 to+5.0 points. Depending on the MID approach, 32% - 41% of patients achieved a clinically meaningful improvement in HRQoL. Approximately one in three patients with IC reported a clinically meaningful improvement in HRQoL after three months of SET. The range of MID and SCB values provides caregivers with an idea of how much change in VascuQoL-6 scores is considered relevant or substantial by their patients. Applying cutoff points for MID and SCB may optimise the interpretation of trial results and may help to set a benchmark for success of SET.

Defining Clinically Significant Outcomes for Revision Arthroscopic Rotator Cuff Repair (230)

Objectives:While clinically significant outcomes including Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB), and Patient Acceptable Symptom State (PASS) have been defined in primary rotator cuff repair (RCR), these values have not been established in revision RCR. Revision cases may be associated with lower absolute improvement compared to primary cases, and outcomes should therefore be assessed against revision-specific clinically significant differences. The purpose of this study was to define clinically significant outcomes in American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Constant scores, and to investigate factors associated with achievement of significant improvement following revision arthroscopic RCR. We hypothesized that MCID, SCB, and PASS values would be lower than those reported for primary RCR patients.Methods:A retrospective review of revision RCRs from July 2014 through June 2019 was performed. Patients who did not complete any patient reported outcomes (PROs) and those who underwent superior capsular reconstructions were excluded; graft augmentations were included. MCID was calculated with the distribution-based method, whereas SCB and PASS were calculated using anchor-based methodology from postoperative PRO scores. The SCB was determined by comparing the PRO scores of the substantial improvement and control patient cohorts, and PASS was determined by comparing the PRO scores of patients responding as satisfied and unsatisfied with their postoperative outcome. Receiver operating characteristic (ROC) curves and area under the curve (AUC) analysis were used to calculate optimal threshold scores corresponding to achievement of the SCB and PASS. Optimal thresholds were determined through maximization of sensitivity and specificity via Youden’s index. This process was repeated for each questionnaire (ASES, SANE, and Constant). Wilcoxon signed-rank paired tests were used to assess improvement in PRO scores from baseline. Threshold analysis to determine if any preoperative PRO scores were sufficiently predictive of achieving the MCID, SCB, or PASS were performed.Results:A total of 97 patients were identified and 54 patients (51 anchor responses) answered 1-year PROs. All PROs demonstrated significant increases from baseline to 1-year postoperatively (all P < 0.001). There was a gain of 22.4, 19.9, and 5.7 points for ASES, SANE, and Constant from baseline, respectively. MCID was 13.7, 14.1, and 4.2 for ASES, SANE, and Constant, respectively (Table 1). Values for SCB using the physical function and pain anchors, and PASS using the satisfaction anchor are demonstrated in Table 1. For physical function improvement, 26 patients (51.0%) had some degree of improvement, 15 patients (29.4%) had no change or negligible change in their status, and 10 patients (19.6%) were worse based on the anchor question. For the pain anchor, 24 patients (47.1%) had some degree of pain improvement, 16 patients (31.4%) had no change or negligible change in their status, and 11 patients (21.6%) were worse. Preoperative PRO score thresholds that were predictive of achieving MCID, SCB, and PASS are presented in Table 2. There were no significant effects of sex on attaining any clinically significant outcome, but a greater age was associated with a higher likelihood of achieving SCB (r = 0.299, p = 0.043) on Constant. BMI was negatively correlated with achieving SCB on SANE (r = -0.383, p = 0.009), while WC status was negatively correlated with achievement of SCB (13.3% WC vs 58.9% non-WC, p = 0.005) and PASS (13.3% WC vs 58.9% non-WC, p = 0.029) on SANE.Conclusions:In this study, we defined MCID, SCB, and PASS values at 1-year for ASES, SANE, and Constant in patients undergoing revision RCR. Our MCID values were higher for ASES but lower for SANE and Constant compared to prior studies on clinically significant outcomes in primary RCR. Our findings suggest different clinical thresholds should be used in the revision RCR population.

Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptom State of Outcome Measures Relating to Shoulder Pathology and Surgery: a Systematic Review.

To provide a comprehensive summary of available literature on the minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) of patient-reported outcome measures (PROMs) for various shoulder conditions and outcomes and to identify factors that influence these metrics. Over the past 2years, there has been an increasing interest in utilizing MCID, SCB, and PASS as a gauge to evaluate the success of an intervention for shoulder conditions. Efforts at calculating these thresholds have yielded multiple and inconsistent values and are further compounded by the proliferation of different PROMs in the shoulder literature. The MCID, SCB, and PASS values of shoulder PROMs vary widely with study-specific characteristics, including patient demographics, shoulder pathology, treatment, shoulder instrument, study methodology, and calculation method. The differences in these factors are not inconsequential and could lead to large discrepancies in threshold values. It is crucial that clinicians are mindful of these variables when designing future studies to calculate these metrics or when utilizing previously published values to determine the success of an intervention.

Minimal Clinically Important Difference, Substantial Clinical Benefit, and Patient Acceptable Symptomatic State After Arthroscopic Rotator Cuff Repair

Background: Minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) are emerging criteria for patient-based treatment assessments. However, few studies have investigated these measures after rotator cuff repair. Purpose: (1) To determine MCID, SCB, and PASS values for pain visual analog scale (pVAS), Single Assessment Numeric Evaluation (SANE), American Shoulder and Elbow Surgeons (ASES) score, and University of California, Los Angeles (UCLA) score after arthroscopic rotator cuff repair. (2) To determine factors for achieving the MCID, SCB, and PASS. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: We analyzed prospectively collected data from a rotator cuff surgery registry between March 2018 and February 2019. Eighty-two patients were included, and anchor questions for deriving MCID, SCB, and PASS values were applied at 1-year follow-up after the surgery. The MCID and SCB for the pVAS, ASES, SANE, and UCLA scores were then derived via 2 methods: a sensitivity- and specificity-based approach, which was used alone to derive PASS values, and a between-patients approach. Additionally, univariable and multivariable logistic regression analyses were performed to determine factors for achieving the MCID, SCB, and PASS. Results: All 4 scores showed acceptable areas under the curve. MCID, SCB, and PASS values for the pVAS were 1.5, 2.5, and 1.7; for ASES scores, 21.0, 26.0, and 78.0; for SANE, 13.0, 20.0, and 71.0; and for UCLA scores, 6.0, 8.0, and 23.0, respectively. Poor preoperative scores demonstrated significantly higher odds ratios (ORs) for achieving the MCID and SCB and lower ORs for achieving the PASS. Retear, large to massive tear, and older age showed lower ORs for achieving the MCID or SCB. For PASS items, male sex and biceps tenodesis had higher ORs, and older age had lower ORs. MCID, SCB, and PASS values per the sensitivity- and specificity-based approach were applied in factor analyses. Conclusion: Reliable MCID, SCB, and PASS values were obtained from patient evaluations 1 year after arthroscopic rotator cuff surgery. Poor preoperative score (MCID and SCB), male sex, and biceps tenodesis showed higher ORs, whereas poor preoperative score (PASS), retear, large to massive tear, and older age demonstrated lower ORs.

Unique Substantial Clinical Benefit Values for the 12-Item International Hip Outcome Tool Based on Preoperative Level of Function

To define unique substantial clinical benefit (SCB) values for improvement on the 12-item International Hip Outcome Tool (iHOT-12) based on a preoperative self-rating of function in patients undergoing hip arthroscopy for intra-articular pathology. This was a retrospective review of prospective collected data on patients having hip arthroscopy for labral and chondral pathology and femoroacetabular impingement. On preoperative assessment and 1-year (+/-1 month) follow-up, subjects completed the iHOT-12 and a self-categorical rating of function ("severely abnormal," "abnormal," "nearly normal," or "normal"). Separate receiver operator characteristic analyses were performed for each preoperative categorical self-rating of function to determine unique SCB values for improvement-based changes in self-rating of function. Of 1034 eligible patients, 733 (71%) subjects met the inclusion criteria. Subjects consisted of 537 (73%) female and 196 (27%) male subjects with a mean age of 35.3 years (standard deviation 13). At a mean of 352 (standard deviation 21) days postsurgery, changes in iHOT-12 scores of 22, 28, and 27 points were associatedwith acceptable accuracy in identifying those who had an improved function rating when reporting a "severely abnormal," abnormal," and "nearly normal" rating on preoperative assessment, respectively. The accuracy of these SCB values in predicting improvement was different depending on the patient's preoperative rating of function. The accuracy of the SCB values in predicting improvement in those who had a "nearly normal" rating of function was not as accurate (area under the curve= 0.73) compared with those who had a "severely abnormal" or "abnormal" rating of function on preoperative assessment (area under the curve= 0.89; 0.89). This study provides surgeons with unique SCB values for the iHOT-12 based on a preoperative rating function and may allow for a more precise interpretation of score changes. SCB values of 22, 28, and 27 points on the iHOT-12 at 1-year (+/-1 month) follow-up identified those who had an improved function rating, when reporting a "severely abnormal," abnormal," and "nearly normal" rating on preoperative assessment, respectively. III, retrospective comparative study.

Minimal Clinically Important Difference and Substantial Clinical Benefit Values for a Pain Visual Analog Scale After Hip Arthroscopy

To define minimal clinically important difference (MCID) and substantial clinical benefit (SCB) values for a pain visual analog scale (VAS) in patients undergoing hip arthroscopy for femoroacetabular impingement or chondrolabral pathology. This was a retrospective review of prospective collected data on patients having hip arthroscopy for femoroacetabular impingement and/or chondrolabral pathology. On initial assessment and follow-up between 335 and 395days postsurgery, subjects completed a pain VAS and categorical self-rating of function. MCID was calculated using one-half the standard deviation (SD) of the change in 1-year pain VAS values. Receiver operator characteristic analysis was performed to determine SCB values. A change in SCB value was determined based on change in categorical self-rating of function to create "improved" and "not improved" groups. Absolute postoperative SCB scores were calculated to determine scores that would be associated with "normal" or "abnormal" function ratings. Of 1,034 eligible patients, 733 (71%) met the inclusion criteria, with 537 (73%) women and 196 (27%) men having a mean age of 35.3years (SD 13). At a mean of 352 (SD 21) days postsurgery, 536 (73%) were in the improved group and 197 (27%) in the not improved group. MCID was -15.0mm. A change of -22.7mm on the pain VAS was able to identify those that improved with high sensitivity (0.74) and specificity (0.63). Values of ≤10.4mm and ≥29.0mm were cutoffs identifying subjects that rated their function as normal or abnormal, respectively, with high sensitivity (0.79 and 0.76) and specificity (0.88 and 0.76). This study provides surgeons with information to help interpret pain VAS values at a follow-up period ranging from 335 to 395days with MCID and SCB values of -15.0mm and -22.7mm, respectively. Additionally, a patient who assesses a pain level at ≤10.4mm is likely to have a normal rating of function, whereas a patient who assesses a pain level at ≥29.0mm is likely to have an abnormal rating of function. III, retrospective comparative study.

Minimal clinically important differences and substantial clinical benefits for Knee Society Scores.

There is a paucity of literature defining the minimal clinically important difference (MCID) for the Knee Society Scores (KSS) after total knee arthroplasty (TKA), and no data on the substantial clinical benefit (SCB) for KSS have been reported. The purpose of this study was to determine MCID and SCB for the KSS in patients with primary TKA. The median age of patients was 71.6 (range 50-88) years, and 60.3% were females 507 patients with TKA were prospectively enrolled. Patients completed the KSS before surgery and at second postoperative year. The MCID values of the KSS were estimated using anchor-based method, distribution-based method and receiver operating characteristic (ROC) curve analysis with calculation of the area under curve (AUC). SCB was estimated using ROC. The MCID for KSS-knee score was 7.2 points by the anchor-based method, 7.2 by the distribution-based method, and using a ROC analysis the cutoff point was 8.9 points with an AUC of 0.75. For KSS-function score, the MCID values were 9.7, 6.3, and 10.3 (AUC 0.71), respectively. SCB values were 39.7 points (AUC 0.74) for the KSS-knee score, and 38.6 (AUC 0.76) for the KSS-function score. Logistic regression showed age and Charlson index to negatively affect the changes in KSS. Different methods for MCID calculation lead to different results. With the use of ROC curve analysis, patients with an improvement of at least 9 points for KSS-knee and 10 points for KSS-function scores experience a clinically important change, whereas those who have at least an improvement of 40 points for KSS-knee and 39 points for KSS-function scores experience a substantial clinical benefit. These findings can ensure clinical improvement from the patient's perspective and also aid in interpreting results from clinical studies. III.