Establishing the Patient-Acceptable Symptom State for the Numeric Rating Scale-Pain Score in a Postoperative Non-Shoulder Hand and Upper-Extremity Population.

PURPOSE: The patient-acceptable symptom state (PASS) is a threshold score on a patient-reported outcome measurement beyond which patients consider themselves "well." Our purpose was to establish the PASS for the numeric rating scale (NRS) for pain in a 1-year postoperative hand surgery population. METHODS: This retrospective study included adult patients undergoing non-shoulder upper-extremity surgery at a single, tertiary medical center identified over a 9-month period. At 1 year after surgery, NRS pain and responses to a pain-specific anchor question were collected. Patients were dichotomized based on achieving "PASS(+)" or failing to achieve "PASS(-)" an acceptable symptom state based upon their response to a pain-specific anchor question. Threshold values of a PASS(+) state were calculated for the NRS pain score using the following three methods: (1) mean score of PASS(+) patients, (2) Tubach method (75th percentile threshold for PASS(+) patients), and (3) the Youden index (receiver operating curve analysis to maximize sensitivity and specificity). RESULTS: Of 233 included patients, mean age was 54 years (±17), and 58% (n = 136) were women. Mean NRS pain scores differed between PASS(+) and PASS(-) patients (0.7 ± 1.2 vs 3.8 ± 2.7, respectively). PASS(-) patients were more likely to be non-White and have a diagnosed psychiatric comorbidity. Patient-acceptable symptom state estimates ranged from 0.73 to 2.1 for NRS pain, depending on the calculation method (0.73 for the mean score method, 1.0 for the Tubach method, and 2.1 for the Youden index). The area under the curve for the Youden index method was 0.86 consistent with excellent discrimination. CONCLUSIONS: We propose the value of 2.1 to represent the PASS threshold for the NRS pain score in this population. CLINICAL RELEVANCE: This PASS value should be used when interpreting NRS pain score outcomes at a population level. This threshold is expected to yield excellent discrimination for patient satisfaction when applied to a postoperative hand surgery population.

Anterior Cervical Decompression and Fusion for Neck Pain in Patients with Cervical Spondylosis: Pooled Results of Three Prospective Cohort Studies.

INTRODUCTION: Currently, there is a lack of large-scale prospective cohort data to explore the response of neck pain to anterior cervical decompression and fusion (ACDF). The aim of this study was to investigate whether patients with neck pain can achieve consistent neck pain relief following ACDF regardless of preoperative neurological symptoms and number of surgical segments. MATERIALS AND METHODS: The study was a pooled analysis of 3 multicenter prospective cohort studies. Patients with cervical radiculopathy and/or myelopathy with significant neck pain (visual analog scale [VAS] ≥ 4) who underwent ACDF were included. Neck pain VAS scores (VAS-neck) were collected at preoperative and postoperative follow-up time points (3 months, 6 months, and 1 year). Subgroup analyses were conducted for patients with radiculopathy, myelopathy, or myeloradiculopathy, as well as for single- versus multi-segment ACDF. RESULTS: A total of 237 patients were confirmed. Patients showed significant improvement in VAS-neck at all follow-up time points compared with baseline (P < 0.001 for each). In the first year after surgery, VAS-neck were reduced by 3.3 points (57.0%) on average, and the rates of achieving minimum clinically important difference and patient acceptable symptom state were 72.2% and 73.8%, respectively. Meanwhile, one year after surgery, there was no significant difference in ΔVAS-neck, recovery rate, minimum clinically important difference, and patient acceptable symptom state attainment rate between the radiculopathy, myelopathy and myeloradiculopathy groups, and the same trend was observed between the single-segment and multi-segment groups. CONCLUSIONS: This study found that ACDF significantly improved neck pain in patients with cervical spondylosis, regardless of preoperative neurological symptoms and number of surgical segments.

Establishing minimal clinically important differences and patient acceptable symptom state thresholds following birmingham hip resurfacing.

INTRODUCTION: Birmingham Hip Resurfacing (BHR) has emerged as a compelling and innovative alternative to total hip arthroplasty (THA), especially among young, active patients. However, the Minimal Clinically Important Difference (MCID) and the Patient Acceptable Symptom State (PASS) thresholds have not yet been determined for patients undergoing BHR. Therefore, the current study aimed to (1) determine the MCID and PASS thresholds for both the Hip disability and Osteoarthritis Outcome Score (HOOS)-Pain and HOOS physical function shortform (PS), for patients who underwent BHR; and (2) identify factors influencing the achievement of MCID and PASS for HOOS-Pain and HOOS-PS. METHODS: Prospectively collected data from patients undergoing BHR was analyzed. Patients with osteoarthritis and completed preoperative and 1-year postoperative PROMs were included. Distribution-based and anchored-based approaches were used to estimate MCID and PASS, respectively. The optimal cut-off point for PASS thresholds was calculated using the Youden index. RESULTS: MCID for HOOS-Pain and PS were calculated to be 9.2 and 9.3, respectively. The PASS threshold for HOOS-Pain and PS were ≥ 77.7 and ≥ 87.3, respectively. The current study identified several factors affecting postoperative achievement of thresholds. Baseline Mental Component Summary (MCS) scores were a predictor for achieving MCID for postoperative HOOS-Pain, achieving MCID for postoperative HOOS-PS, achieving PASS for postoperative HOOS-Pain, and achieving PASS for postoperative HOOS-PS. Furthermore, baseline HOOS-Pain was a significant predictor for achieving MCID for postoperative HOOS-PS, achieving PASS for postoperative HOOS-Pain, and achieving PASS for postoperative HOOS-PS. CONCLUSIONS: MCID and PASS thresholds were established for HOOS-Pain and PS domains following BHR with most patients achieving these clinically meaningful benchmarks. Additionally, several factors affecting achievement of MCID and PASS were identified, including modifiable risk factors that may allow clinicians to implement optimization strategies and further improve outcomes.

Establishment of the Patient Acceptable Symptom State (PASS) for the Achilles Tendon Total Rupture Score in a Swedish Population.

Background: As the use of patient-reported outcome measures (PROMs) is increasing in orthopaedic research, there is also a growing need for a standardized interpretation of these scores, such as the Patient Acceptable Symptom State (PASS), defined as the value beyond which patients consider themselves well. The Achilles tendon Total Rupture Score (ATRS) is the only PROM specific for Achilles tendon ruptures. Purpose: To establish the PASS for the ATRS in a Swedish population. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Patients treated for an acute Achilles tendon rupture at a single institution in Sweden (injured between July 1, 2018, and December 31, 2020) were asked to participate in this study. The patients completed a questionnaire consisting of the ATRS and an anchor question: "How satisfied are you with the result of your treatment?" Receiver operating characteristic curve analysis was performed to calculate the PASS threshold for a positive response to the anchor question. Results: Of 516 eligible patients, 316 (61%) were included. The time from injury to completion of the questionnaire ranged from 12 to 27 months. The PASS threshold for the ATRS was found to be 75. The median ATRS of all patients was 80; 66% of patients reached an ATRS ≥75. Overall, 79% of patients were satisfied with the results of their treatment. Conclusion: The estimated PASS for the ATRS was 75 in the general Swedish population at 12 to 27 months after an acute Achilles tendon rupture.

The attainment of a patient acceptable symptom state in patients undergoing revision spine fusion.

INTRODUCTION: Revision lumbar fusion is most commonly due to nonunion, adjacent segment disease (ASD), or recurrent stenosis, but it is unclear if diagnosis affects patient outcomes. The primary aim of this study was to assess whether patients achieved the patient acceptable symptom state (PASS) or minimal clinically important difference (MCID) after revision lumbar fusion and assess whether this was influenced by the indication for revision. METHODS: We retrospectively identified all 1-3 level revision lumbar fusions at a single institution. Oswestry Disability Index (ODI) was collected at preoperative, three-month postoperative, and one-year postoperative time points. The MCID was calculated using a distribution-based method at each postoperative time point. PASS was set at the threshold of ≤ 22. RESULTS: We identified 197 patients: 56% with ASD, 28% with recurrent stenosis, and 15% with pseudarthrosis. The MCID for ODI was 10.05 and 10.23 at three months and one year, respectively. In total, 61% of patients with ASD, 52% of patients with nonunion, and 65% of patients with recurrent stenosis achieved our cohort-specific MCID at one year postoperatively with ASD (p = 0.78). At one year postoperatively, 33.8% of ASD patients, 47.8% of nonunion patients, and 37% of patients with recurrent stenosis achieved PASS without any difference between indication (p = 0.47). CONCLUSIONS: The majority of patients undergoing revision spine fusion experience significant postoperative improvements regardless of the indication for revision. However, a large proportion of these patients do not achieve the patient acceptable symptom state. While revision spine surgery may offer substantial benefits, these results underscore the need to manage patient expectations.

Patient Acceptable Symptom State Thresholds for IKDC-SKF and KOOS at the 10-Year Follow-up After Anterior Cruciate Ligament Injury: A Study From the Delaware-Oslo ACL Cohort.

Background: Clinicians need thresholds for the Patient Acceptable Symptom State (PASS) and Treatment Failure to interpret group-based patient-reported outcome measures after anterior cruciate ligament (ACL) injury. Validated thresholds that are crucial for accurately discerning patient symptom state and facilitating effective interpretation have not been determined for long-term follow-up after ACL injury. Purpose: To calculate and validate thresholds for PASS and Treatment Failure for the International Knee Documentation Committee Subjective Knee Form (IKDC-SKF) and the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales at the 10-year follow-up after ACL injury. Study Design: Cohort study; Level of evidence, 3. Methods: A total of 163 participants with unilateral ACL injury (treated with reconstruction or rehabilitation alone) from the Delaware-Oslo ACL Cohort were included. Thresholds for PASS were calculated for IKDC-SKF and KOOS subscales using anchor-based predictive modeling and receiver operating characteristic (ROC) analysis. Too few participants had self-reported Treatment Failure to calculate thresholds for that outcome. Nonparametric bootstrapping was used to derive 95% CIs. The criterion validity of the predictive modeling and ROC-derived thresholds were assessed by comparing actual patient-reported PASS outcome with the calculated PASS outcome for each method of calculation and calculating their positive and negative predictive values with respect to the anchor questions. Results: A total of 127 (78%) participants reported satisfactory symptom state. Predictive modeling PASS thresholds (95% CIs) were 76.2 points (72.1-79.4 points) for IKDC-SKF, 85.4 points (80.9-89.2 points) for KOOS Pain, 76.5 points (67.8-84.7 points) for KOOS Symptoms, 93.8 points (90.1-96.9 points) for KOOS activities of daily living, 71.6 points (63.4-77.7 points) for KOOS Sports, and 59.0 points (53.7-63.9 points) for KOOS quality of life (QoL). Predictive modeling thresholds classified 81% to 93% of the participants as having satisfactory symptom state, whereas ROC-derived thresholds classified >50% as unsatisfied. The thresholds for IKDC-SKF, KOOS Sports, and KOOS QoL resulted in the most accurate percentages of PASS among all identified thresholds and therefore demonstrate the highest validity. Conclusion: Predictive modeling provided valid PASS thresholds for IKDC-SKF and KOOS at the 10-year follow-up after ACL injury. The thresholds for IKDC-SKF, KOOS Sports, and KOOS QoL should be used when determining satisfactory outcomes. ROC-derived thresholds result in substantial misclassification rates of the participants who reported satisfactory symptom state.

Should We Wait for Bone-on-Bone Arthritis? Equivalent Clinical Outcomes in Patients Requiring Advanced Imaging Before Primary Total Hip Arthroplasty.

BACKGROUND: Plain radiographs remain the standard for diagnosing osteoarthritis (OA). Total hip arthroplasty (THA) is generally offered only for advanced OA by plain radiographs. Advanced imaging is used as an adjunct to assess OA severity in cases of progressive symptoms with less advanced OA by plain radiographs. The objective of this study was to compare outcomes following THA in patients who have advanced OA visualized by plain radiographs to patients who have less severe OA visualized by plain radiographs. METHODS: From February 2016 to February 2020, 93 patients who had Kellgren-Lawrence (KL) grade 0 to 2 OA and underwent THA were identified. The median age was 65 years, and 55% were women. They were matched 1:3 to patients who underwent THA for KL 4 OA based on age, sex, body mass index, and Charlson Comorbidity Index. The primary outcome was achievement of the Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) minimum clinically important difference, substantial clinical benefit, and patient-acceptable symptom state at 1 year postoperatively. RESULTS: There was no difference between the KL 0 to 2 and KL 4 cohorts in the achievement of HOOS JR minimum clinically important difference (86 versus 85.6%, P = .922), substantial clinical benefit (81.7 versus 80.2%, P = .751), or patient-acceptable symptom state (89.2 versus 85.6%, P = .374). The KL 0 to 2 cohort had a similar improvement in their 2-year HOOS JR (42.5 versus 38.6, P = .019). CONCLUSIONS: In this series, there was no difference in outcomes following primary THA between patients who have severe OA on plain radiographs (KL 4) compared to those who have less severe OA (KL 0 to 2). In the setting of severe symptoms and the absence of advanced OA on radiographs, advanced imaging can be used to guide treatment and select patients who could benefit from THA.

Unicompartmental knee arthroplasty improves mental health in patients with single compartment knee osteoarthritis.

PURPOSE: The purpose of this study was to determine if preoperative mental health status improves following unicompartmental knee arthroplasty (UKA) in patients with single compartment knee osteoarthritis (OA). METHODS: A total of 163 patients underwent UKA [115 (71%) medial, 48 (29%) lateral] (mean age = 65 ± 11) completed preoperative and minimum 2-year postoperative veterans RAND 12 item health survey (VR-12) mental component score (MCS). VR-12 MCS was the primary outcome measure. Secondary measures included VR-12 physical component summary score (PCS), knee osteoarthritis outcome score (KOOS) and KOOS patient acceptable symptom state at the final follow-up. RESULTS: The median VR-12 MCS improved from 50.5 [interquartile range (IQR): 43.7-56.8] to 55.0 [IQR: 52.3-57.0] (p < 0.001) at a mean follow-up of 9.5 ± 4 years (range 2-19 years) following UKA. Preoperative VR-12 MCS was significantly correlated with patients postoperative VR-12 PCS (ρ = 0.294, p < 0.01), KOOS pain (ρ = 0.201, p = 0.012), KOOS ADL (ρ = 0.243, p = 0.002) and KOOS quality of life (ρ = 0.233, p < 0.01). Sixty-three (39%) patients improved from low VR-12 MCS (<50) to normal VR-12 MCS (≥50). One hundred forty-two (87%) achieved a normal VR-12 MCS score (≥50) postoperatively. CONCLUSION: At a mean of 10-year follow-up, patients who underwent UKA for single compartment osteoarthritic knee pain demonstrated significant improvement in mental health scores. UKA resulted in normal mental health in a majority of patients (87%). The resultant improved mental health scores were associated with improved patient pain and activities of daily living. LEVEL OF EVIDENCE: Level III retrospective cohort study.

Effect of age and gender in rates of achieving minimal clinically important difference and patient-acceptable symptom state 2 years after arthroscopic superior capsular reconstruction.

PURPOSE: This study aimed to evaluate patient-reported outcome measures (PROMs) and the effects of gender and age on achieving clinically significant outcomes in patients undergoing arthroscopic superior capsular reconstruction (ASCR) with a minimum 2-year follow-up. METHODS: Patients undergoing ASCR for irreparable rotator cuff tear between 2013 and 2020 were reviewed. Preoperative and minimum 2-year postoperative PROMs were collected, including American Shoulder and Elbow Surgeons (ASES), Constant, single assessment numeric evaluation (SANE), and visual analog scale (VAS) scores. Minimal clinically important difference (MCID) and patient-acceptable symptomatic state (PASS) were calculated for each functional score and analyzed according to age and gender. The percentages of patients achieving MCID and PASS were recorded. RESULTS: The study included 83 patients, with a mean follow-up of 3.5 ± 1.4 years. Significant improvements were found in ASES, Constant, SANE, and VAS for all groups based on gender and age. Based on receiver-operating characteristic curves, all scores had acceptable areas under the curve for PASS. Values for PASS and MCID were 81.5 and 10.3 for ASES; 61.5 and 6.2 for Constant; 82.5 and 11.5 for SANE and 1.5 and 1.1 for VAS, respectively. Analysis of achieving MCID and PASS showed no difference between the groups in the majority of outcome measures. However, female patients achieved the SANE thresholds for PASS at significantly higher rates than male patients. Patients ≥65 years old achieved ASES and Constant thresholds for MCID at significantly higher rates than patients ˂65 years old. CONCLUSION: Most patients achieved MCID and PASS at a 2-year follow-up. Patients showed comparable rates of MCID and PASS achievement on most outcome tools based on age and gender. Female patients achieved PASS on SANE at significantly higher rates than male patients and older patients achieved MCID on ASES and Constant at higher rates than young patients. Thus, age is a stronger factor for achieving MCID than gender. LEVEL OF EVIDENCE: Level II.

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.

Patient acceptable symptom state and treatment failure threshold values for work productivity and activity Impairment and EQ-5D-5L in osteoarthritis.

OBJECTIVE: To estimate patient acceptable symptom state (PASS) and treatment failure (TF) threshold values for Work Productivity and Activity Impairment (WPAI) measure and EQ-5D-5L among people with hip or knee osteoarthritis (OA) 3 and 12 months following participation in a digital self-management intervention (Joint Academy®). METHODS: Among the participants, we computed work and activity impairments scores (both 0-100, with a higher value reflecting higher impairment) and the Swedish hypothetical- (range: - 0.314 to 1) and experience-based (range: 0.243-0.976) EQ-5D-5L index scores (a higher score indicates better health status) at 3- (n = 14,607) and 12-month (n = 2707) follow-ups. Threshold values for PASS and TF were calculated using anchor-based adjusted predictive modeling. We also explored the baseline dependency of threshold values according to pain severity at baseline. RESULTS: Around 42.0% and 48.3% of the participants rated their current state as acceptable, while 4.2% and 2.8% considered the treatment had failed at 3 and 12 months, respectively. The 3-month PASS/TF thresholds were 16/29 (work impairment), 26/50 (activity impairment), 0.92/0.77 (hypothetical EQ-5D-5L), and 0.87/0.77 (the experience-based EQ-5D-5L). The thresholds at 12 months were generally comparable to those estimated at 3 months. There were baseline dependencies in PASS/TF thresholds with participants with more severe baseline pain considering poorer (more severe) level of WPAI/EQ-5D-5L as satisfactory. CONCLUSION: PASS and TF threshold values for WPAI and EQ-5D-5L might be useful for meaningful interpretation of these measures among people with OA. The observed baseline dependency of estimated thresholds limits their generalizability and values should be applied with great caution in other settings/populations.

What Are the Diagnosis-Specific Thresholds of Minimal Clinically Important Difference and Patient Acceptable Symptom State in Hip Disability and Osteoarthritis Outcome Score After Primary Total Hip Arthroplasty?

BACKGROUND: This study aimed to determine the minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) thresholds for Hip Disability and Osteoarthritis Outcome Score (HOOS) pain, physical short form (PS), and joint replacement (JR) 1 year after primary total hip arthroplasty stratified by preoperative diagnosis of osteoarthritis (OA) versus non-OA. METHODS: A prospective institutional cohort of 5,887 patients who underwent primary total hip arthroplasty (January 2016 to December 2018) was included. There were 4,184 patients (77.0%) who completed a one-year follow-up. Demographics, comorbidities, and baseline and one-year HOOS pain, PS, and JR scores were recorded. Patients were stratified by preoperative diagnosis: OA or non-OA. Minimal detectable change (MDC) and MCIDs were estimated using a distribution-based approach. The PASS values were estimated using an anchor-based approach, which corresponded to a response to a satisfaction question at one year post surgery. RESULTS: The MCID thresholds were slightly higher in the non-OA cohort versus OA patients. (HOOS-Pain: OA: 8.35 versus non-OA: 8.85 points; HOOS-PS: OA: 9.47 versus non-OA: 9.90 points; and HOOS-JR: OA: 7.76 versus non-OA: 8.46 points). Similarly, all MDC thresholds were consistently higher in the non-OA cohort compared to OA patients. The OA cohort exhibited similar or higher PASS thresholds compared to the non-OA cohort for HOOS-Pain (OA: ≥80.6 versus non-OA: ≥77.5 points), HOOS-PS (OA: ≥83.6 versus non-OA: ≥83.6 points), and HOOS-JR (OA: ≥76.8 versus non-OA: ≥73.5 points). A similar percentage of patients achieved MCID and PASS thresholds regardless of preoperative diagnosis. CONCLUSIONS: While MCID and MDC thresholds for all HOOS subdomains were slightly higher among non-OA than OA patients, PASS thresholds for HOOS pain and JR were slightly higher in the OA group. The absolute magnitude of the difference in these thresholds may not be sufficient to cause major clinical differences. However, these subtle differences may have a significant impact when used as indicators of operative success in a population setting.

The Delaware-Oslo ACL Cohort treatment algorithm yields superior outcomes to usual care 9-12 years after anterior cruciate ligament reconstruction.

PURPOSE: Patient-reported outcomes were compared between participants who followed the treatment algorithm of the Delaware-Oslo ACL Cohort, consisting of progressive preoperative and postoperative rehabilitation, patient education, clinical testing and shared decision-making about treatment choice, and those who followed usual care 9-12 years after anterior cruciate ligament reconstruction (ACLR). METHODS: Participants with primary ACLR were included from the Norwegian arm of the Delaware-Oslo ACL Cohort and the Norwegian Knee Ligament Registry (usual care). The Knee Injury and Osteoarthritis Outcome Score (KOOS) subscale scores and the International Knee Documentation Committee-Subjective Knee Form (IKDC-SKF) scores were compared. KOOS scores for the usual care group were converted to IKDC-SKF scores with recently published validated crosswalk. The percentages of participants with scores above predefined thresholds for patient acceptable symptom state (PASS) were also calculated. RESULTS: Eighty of 100 (80%) participants from the Delaware-Oslo ACL Cohort and 1588 of 3248 (49%) from the usual care group participated in the follow-up. Participants from the Delaware-Oslo ACL Cohort had higher KOOS subscale (p < 0.001) and IKDC-SKF scores (p < 0.001), and a higher percentage reached PASS (84%-96% vs. 62%-76%, p ≤ 0.002) for KOOS Pain, symptoms, activities of daily living and sports compared to the usual care group. No significant differences were found for KOOS quality of life scores (not significant [n.s.]) or PASS percentages (80% vs. 74%, n.s.). CONCLUSION: Participants with ACLR who followed the Delaware-Oslo ACL Cohort treatment algorithm had reduced knee symptoms, superior function and higher percentages of satisfactory outcomes than participants who followed usual care. LEVEL OF EVIDENCE: Level II.

Effect of Patient Characteristics on the Minimal Clinically Important Difference and Patient Acceptable Symptom State Thresholds After Arthroscopic Bankart Repair.

BACKGROUND: There is scarce literature on clinically significant values after arthroscopic Bankart repair (ABR). PURPOSE: To determine the minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS) thresholds at 1 year for the Rowe and Athletic Shoulder Outcome Scoring System (ASOSS) scores after ABR and to determine the effect of patient characteristics on these metrics after ABR. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A retrospective review of patients undergoing ABR from a single institution between January 2017 and January 2020 was performed. Patients with at least 1 episode of instability and a minimum follow-up of 12 months were included. The exclusion criteria were as follows: bony defects of >20% on the anteroinferior portion of the glenoid based on a preoperative computed tomography scan; engaging Hill-Sachs lesions at 90° of abduction and 90° of external rotation based on an arthroscopic examination; previous surgery on the same shoulder; multidirectional instability or concomitant repair of full-thickness rotator cuff tears; superior labral anterior to posterior lesions; posterior labral tears; or humeral avulsion of the glenohumeral ligament lesions. Patient-reported outcome measures were collected both preoperatively and 1-year postoperatively. Delta was defined as the change between preoperative and 1-year postoperative scores. Distribution-based (one-half the standard deviation of the difference between pre- and postoperative outcome scores) and anchored-based approaches (response to a satisfaction question at 1 year) were used to estimate the MCID and the PASS, respectively. The optimal cutoff point, where sensitivity and specificity were maximized, and the percentage of patients achieving those thresholds were also calculated. RESULTS: Overall, 190 patients were included. The distribution-based MCID for the Rowe and ASOSS scores were calculated to be 8.2 and 8.7, respectively. The rate of patients who achieved MCID thresholds was 96% for the Rowe and 96% for ASOSS scores. The PASS threshold for the Rowe and ASOSS scores were ≥80 and ≥90, respectively. The rate of patients who achieved PASS scores after ABR were 86% and 83%, respectively. The MCID and PASS values showed great variability based on sex (men: 8.5 and ≥85 for Rowe / 8.9 and ≥90 for ASOSS, respectively, vs women: 6.7 and ≥73 for Rowe / 8.1 and ≥75 for ASOSS), age (≥21: 8.4 and ≥80 / 9.2 and ≥90 vs <21: 7.8 and ≥75 / 7.7 and ≥85), sports participation (sports: 8.8 and ≥85 / 9.5 and ≥90 vs no sports: 8.1 and ≥75 / 8.6 and ≥80), and type of athlete (competitive: 8.4 and ≥85 / 8.9 and ≥87 vs recreational: 7.5 and ≥73 / 8.1 and ≥68). CONCLUSION: This study identified the MCID and PASS thresholds for the Rowe and ASOSS scores at 1 year after ABR. However, these values showed great variability when accounting for different patient characteristics such as sex, age, sports participation, and type of athlete, highlighting the importance of considering individual patient-specific characteristics for optimal treatment decision-making and ensuring treatment success tailored to each patient's unique needs and expectations.

Establishing patient-centered metrics for the knee injury and osteoarthritis outcome score following medial unicompartmental knee arthropalsty.

BACKGROUND: This study aimed to determine the minimal clinically important difference (MCID) and the patient acceptable symptoms state (PASS) threshold for the knee injury and osteoarthritis outcome score (KOOS) pain subscore, KOOS physical short form (PS), and KOOS joint replacement (JR) following medial unicompartmental knee arthroplasty (mUKA). METHODS: Prospectively collected data from 743 patients undergoing mUKA from a single academic institution from April 2015 through March 2020 were analyzed. Patient-reported outcome measures (PROMs) were collected both pre-operatively and 1-year post-operatively. Distribution-based and anchored-based approaches were used to estimate MCIDs and PASS, respectively. The optimal cut-off point and the percentage of patients who achieved PASS were also calculated. RESULTS: MCID for KOOS-pain, KOOS-PS, and KOOS-JR following mUKA were calculated to be 7.6, 7.3, and 6.2, respectively. The PASS threshold for KOOS pain, PS, and JR were 77.8, 70.3, and 70.7, with 68%, 66%, and 64% of patients achieving satisfactory outcomes, respectively. Cut-off values for delta KOOS pain, PS, and JR were found to be 25.7, 14.3, and 20.7 with 73%, 69%, and 68% of patients achieving satisfactory outcomes, respectively. CONCLUSION: The current study identified useful values for the MCID and PASS thresholds at 1 year following medial UKA of KOOS pain, KOOS PS, and KOOS JR scores. These values may be used as targets for surgeons when evaluating PROMS using KOOS to determine whether patients have achieved successful outcomes after their surgical intervention. Potential uses include the integration of these values into predictive models to enhance shared decision-making and guide more informed decisions to optimize patient outcomes. LEVEL OF EVIDENCE: III.

30 years with the Knee injury and Osteoarthritis Outcome Score (KOOS).

This narrative review describes the development and use of patient-reported outcomes over 30 years, focusing on the Knee injury and Osteoarthritis Outcome Score (KOOS). KOOS is a five-subscale patient-reported instrument intended for use from the time of knee injury to the development of osteoarthritis. Numerous studies have confirmed that the psychometric properties of the KOOS and its short-form KOOS-12 are acceptable. More recent research has focused on the use and interpretation of KOOS scores in clinical trials using thresholds, such as minimal important differences, patient-acceptable symptom states, and treatment failure. As an indication of KOOS's popularity, the total 3854 PubMed results for KOOS have increased exponentially since the first KOOS paper was published 25 years ago and now seem to have plateaued at around 650 annually. The selected articles are not based on a systematic search, but on the author's own publications, reading, and literature search that grew organically from that.

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

STUDY DESIGN: Retrospective cohort. OBJECTIVE: 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. METHODS: Patients who underwent primary cervical fusion, discectomy, or laminectomy were included. NDI and global rating change (GRC) data at 6 months/1 year/2 years 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. RESULTS: 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). CONCLUSION: 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.

Knee Injury and Osteoarthritis Outcome Score Interpretation Thresholds at 3 and 12 Months After Arthroscopic Meniscal Surgery. What Changes, and What Stays the Same?

OBJECTIVE: To evaluate the change in minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) thresholds for the Knee injury and Osteoarthritis Outcome Score (KOOS) from 3 to 12 months following arthroscopic meniscus surgery. DESIGN: Retrospective cohort study. METHODS: We included patients from the Knee Arthroscopy Cohort Southern Denmark who had meniscus surgery between 2013 and 2015. We calculated the interpretation threshold values for MIC, PASS, and TF using an anchor-based adjusted predictive modeling method. Thresholds at 3 and 12 months postoperatively were compared to evaluate changes over time. RESULTS: The proportions of people who reported a clinically relevant improvement, or their symptoms being acceptable, increased by 10% to 15% points from 3 to 12 months after surgery. MIC thresholds for the 5 KOOS subscales remained stable from 3 to 12 months with statistically nonsignificant differences (95% confidence intervals) ranging from -0.3 (-3.0, 2.6) to -2.4 (-6.1, 1.3). All PASS thresholds except for quality of life (QOL) decreased by -6.5 (-11.8, -1.5) to -3.7 (-7.1, -0.4) points, indicating that higher symptom levels were accepted at 12 months. In contrast, the proportion reporting their treatment to have failed remained stable over time (19% and 17%). For QOL, a 7.4 (2.0, 13.2) higher TF threshold at 12 months suggested that improved QOL was required to not consider that the treatment had failed. CONCLUSION: More patients reported being improved at 1 year compared to at 3 months following meniscus surgery. The KOOS MIC thresholds were stable over time, whereas time-specific PASS values should be applied after meniscus surgery. J Orthop Sports Phys Ther 2023;53(11):685-702. Epub 3 October 2023. doi:10.2519/jospt.2023.11993.

Symptom and Treatment Satisfaction in Members of the US and Canadian GBS/CIDP Foundations with a Diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy.

INTRODUCTION: Current guidelines for defining good outcomes in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) are predominately defined by experts. At present, we do not have a patient-anchored definition of what constitutes a "good" outcome. Our study aimed to assess the symptom burden of people living with CIDP, as well as satisfaction with treatments and clinical outcomes. METHODS: We conducted an online-survey in CIDP patients registered with the US and Canadian GBS/CIDP foundations. Respondents answered general demographic and clinical questions, as well as satisfaction with current symptom burden and treatments, plus validated outcome measures. RESULTS: A total of 318 individuals with self-reported CIDP completed the online survey, of whom 128 (40%) considered their current disease burden as satisfactory while 190 (60%) did not. Of 305 patients who answered the treatment satisfaction question, 222(74%) were satisfied with their treatments. Patients who were satisfied with their current symptoms had, on average, better scores in quality of life and disease severity scales, although regression modeling showed that only ability to walk, stable symptoms, and health utility scores were associated with symptom satisfaction. Treatment satisfaction was associated with stable symptoms, use of IVIG, and use of one versus no medication. CONCLUSIONS: A high proportion of members of the US and Canadian GBS/CIDP Foundations reporting a diagnosis of CIDP were unsatisfied with current symptoms, despite a high level of overall satisfaction with treatments. There is an unmet need for improving long-term outcomes in people with a diagnosis of CIDP, and for studying patient-centered long-term treatment goals.

Values derived from patient reported outcomes in spine surgery: a systematic review of the minimal clinically important difference, substantial clinical benefit, and patient acceptable symptom state.

PURPOSE: While patient reported outcome measures (PROMs) define value in spine surgery, several values such as minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptom state (PASS) help guide the interpretation of PROMs and identify thresholds of clinical significance. Significant variation exists in reported values and their calculation, so the primary objective of this study was to systematically review the spine surgery literature for metrics of clinical significance derived from PROMs. METHODS: We conducted a query of PubMed/MEDLINE and Scopus databases from inception to January 1, 2023, for studies that derived quantitative metrics (e.g., SCB, MCID, PASS) from PROMs in the setting of spine surgery with minimum 1-year follow-up. Details regarding the specific PROMs were collected including which PROM was measured, whether anchor- or distribution-based methods were utilized, the specific calculations, and the recommended value for a given PROM based on all evaluated calculations. RESULTS: Thirty-seven studies of 21,780 patients were included. The most commonly evaluated PROM-derived value was the MCID (n = 28), followed by PASS (n = 6) and SCB (n = 4). Twenty-one studies only utilized anchor-based calculations, 15 utilized both anchor-based and distribution-based methods, and one only utilized distribution-based calculations. The most commonly evaluated legacy PROMs were the Oswestry Disability Index (ODI) (N = 11, MCID range 4-20) and visual analog scale back pain (N = 5, MCID range 0.5-4.6). All 10 studies that derived SCB or PASS utilized the receiver operating characteristic methods. Among the six studies deriving a PASS value, four only evaluated ODI, identifying PASS ranging from 5 to 22. CONCLUSION: While calculated measures of clinical significance such as MCID, PASS, and SCB exist, significant heterogeneity exists in the current literature. Current shortcomings include a wide variability of reported value thresholds across the literature, and limited applicability to more heterogenous patient populations than the targeted cohorts included in published investigations. Continued investigations that apply these methods to heterogenous, large-scale populations can help increase generalizability and validity of these measures. LEVEL OF EVIDENCE: III.