Patient Acceptable Symptom State Thresholds Research Articles

Preoperative patient-reported outcome measures predict minimal clinically important difference and patient-acceptable symptomatic state following arthroscopic Bankart repair.

The aims of this study were to validate the minimal clinically important difference (MCID) and patient-acceptable symptom state (PASS) thresholds for Western Ontario Shoulder Instability Index (WOSI), Rowe score, American Shoulder and Elbow Surgeons (ASES), and visual analogue scale (VAS) scores following arthroscopic Bankart repair, and to identify preoperative threshold values of these scores that could predict the achievement of MCID and PASS. A retrospective review was conducted on 131 consecutive patients with anterior shoulder instability who underwent arthroscopic Bankart repair between January 2020 and January 2023. Inclusion criteria required at least one episode of shoulder instability and a minimum follow-up period of 12 months. Preoperative and one-year postoperative scores were assessed. MCID and PASS were estimated using distribution-based and anchor-based methods, respectively. Receiver operating characteristic curve analysis determined preoperative patient-reported outcome measure thresholds predictive of achieving MCID and PASS. MCID thresholds were determined as 169.6, 6.8, 7.2, and 1.1 for WOSI, Rowe, ASES, and VAS, respectively. PASS thresholds were calculated as ≤ 480, ≥ 80, ≥ 87, and ≤ 1 for WOSI, Rowe, ASES, and VAS, respectively. Preoperative thresholds of ≥ 760 (WOSI) and ≤ 50 (Rowe) predicted achieving MCID for WOSI score (p < 0.001). Preoperative thresholds of ≤ 60 (ASES) and ≥ 2 (VAS) predicted achieving MCID for VAS score (p < 0.001). A preoperative threshold of ≥ 40 (Rowe) predicted achieving PASS for Rowe score (p = 0.005). Preoperative thresholds of ≥ 50 (ASES; p = 0.002) and ≤ 2 (VAS; p < 0.001) predicted achieving PASS for the ASES score. Preoperative thresholds of ≥ 43 (ASES; p = 0.046) and ≤ 4 (VAS; p = 0.024) predicted achieving PASS for the VAS. This study defined MCID and PASS values for WOSI, Rowe, ASES, and VAS scores in patients undergoing arthroscopic Bankart repair. Higher preoperative functional scores may reduce the likelihood of achieving MCID but increase the likelihood of achieving the PASS. These findings provide valuable guidance for surgeons to counsel patients realistically regarding their expectations.

The Minimum Patient Acceptable Symptom State for the ACL-Return to Sport after Injury Scale Among Patients Treated With Anterior Cruciate Ligament Reconstruction.

Despite most patients reporting optimal knee function after anterior cruciate ligament reconstruction (ACLR), not all return to their pre-injury level of sport, often due to psychological factors. The ACL-Return to Sport after Injury Scale (ACL-RSI) was developed to measure the emotions, confidence in performance, and risk appraisal among athletes returning to sport. The purpose of this study was to determine the Patient Acceptable Symptom State (PASS) threshold for the ACL-RSI in patients undergoing ACLR. Patients with an ACL injury that required surgical reconstruction were included in this prospective study. All patients underwent ACLR with a bone-patellar tendon-bone autograft and completed the ACL-RSI 12 months postoperatively. An anchor-based approach was used to generate a receiver operating characteristic curve and establish the PASS threshold. Multivariable regression analyses were used to evaluate the effect of age, sex, and baseline score on likelihood of achieving PASS. A total of 113 patients (37% female) with a mean age of 28.1±8.2 years and a mean body mass index of 24.7±3.5 kg/m2 were included. At 12 months postoperatively, the threshold value for the PASS of the ACL-RSI was 40 (robust area under the curve: 0.89; sensitivity: 81%; specificity: 85%). Baseline score, sex, and age had no significant influence on achieving PASS at 12 months postoperatively. In a group of patients undergoing ACLR with bone-patellar tendon-bone autograft, the PASS threshold value was 40 for the ACL-RSI at 12 months postoperatively. The PASS value for the ACL-RSI established from this study can be useful for designing future clinical trials. [Orthopedics. 202x;4x(x):xx-xx.].

Registry-based cohort study comparing percentages of patients reaching PASS for knee function outcomes after revision ACLR compared to primary ACLR

ObjectivesReaching the Patient-Acceptable Symptom State (PASS) threshold for the Knee injury and Osteoarthritis Outcome Score (KOOS) has previously been reported to successfully identify individuals experiencing clinical success after anterior cruciate...

Patient Factors Influencing Outcomes at 12-Year Follow-up of Hip Arthroscopy for Femoroacetabular Impingement

Background: Arthroscopic treatment of femoroacetabular impingement has increased in popularity since the early 2000s when it was first described, although only a few midterm follow-up studies have been published. Purpose: To describe the outcomes of patients undergoing hip arthroscopy for femoroacetabular impingement at a mean 12-year follow-up and to determine the risk factors for failure. Study Design: Case-control study; Level of evidence, 3. Methods: The Non-Arthritic Hip Score (NAHS) and a radiographic evaluation were completed preoperatively and at midterm follow-up. Participants were divided into 2 groups according to their clinical evolution. The success group consisted of patients whose NAHS at the final follow-up was above the established Patient Acceptable Symptom State (PASS) threshold of 81.9, whereas patients who underwent a second surgical intervention or did not reach the PASS threshold at final follow-up were assigned to the failure group. These groups were compared to identify preoperative differences in demographic, pathological, and surgical factors. Results: A total of 95 hips were included, after 23 were lost to follow-up (80.5% follow-up). At a mean follow-up of 12.1 years (range, 9.2-16.0 years), 9 hips required total hip arthroplasty (9.5%), 5 required revision hip arthroscopy (5.3%), 29 did not achieve the NAHS PASS threshold (30.5%), and 52 achieved the NAHS PASS threshold (54.7%). The mean NAHS was 82.4 at final follow-up compared with 66.9 preoperatively (mean difference = 15.5; P < .001). Higher mean body mass index (24.9 vs 23.0; P = .030), older age (30.0 vs 27.2; P = .035), and inferior preoperative lateral joint space width (3.9 vs 4.4; P = .019) were associated with inferior prognosis in the failure group versus success group. Osteoarthritis progression was observed in 69.2% of the failure group and in 34.8% of the success group (P = .082). Labral ossification was observed in 78.3% of all patients, and its lateral projection length was statistically associated with failure (P = .015). Conclusion: At a mean 12-year follow-up, hip arthroscopy for femoroacetabular impingement led to significant clinical improvement, with 55% PASS achievement. In total, 31% of patients were below the PASS threshold, 5% had revision arthroscopy, and only 9% had conversion to total hip arthroplasty for a 45% global failure rate. Increased body mass index, older age, and smaller preoperative lateral joint space width were significant negative prognostic factors. Postoperative degenerative changes were highly prevalent and demonstrated association with failure.

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

IntroductionBirmingham 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.MethodsProspectively 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.ResultsMCID 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.ConclusionsMCID 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.

The Patient Acceptable Symptom State (PASS) after proximal and distal femoral replacement

IntroductionFemoral megaprostheses are used for bone reconstruction surgery in patients with local tumors or who require multiple revisions. Patient reported outcome measures (PROMs) provide a subjective result and, like patient satisfaction, have become an integral part of the outcomes in orthopedics. However, the threshold of satisfaction (PASS: Patient Acceptable Symptom State) has not yet been defined in a French population after this type of arthroplasty. This led us to carry out a retrospective study on a population of patients who received a femoral reconstruction megaprosthesis in order to 1) define the PASS for the Harris Hip Score (HHS), Knee Society Score (KSS) and the Musculoskeletal Tumor Society score (MSTS), 2) study the complications. HypothesisThe PASS threshold for proximal femur and distal femur reconstruction prothesis for the HHS and the KSS, respectively, will be lower than the threshold for these same scores for primary arthroplasty. Materials and methodsForty-four patients who were operated on between 2009 and 2020 were included: 23 received a proximal femur prosthesis and 21 received a distal femur prosthesis. The PASS threshold was defined using an anchoring strategy by analyzing ROC curves for the HSS for the proximal femur, KSS for the distal femur and the MSTS for all the prostheses. Complications were classified according to Henderson. ResultsThe mean follow-up was 4.5 ± 3.6 (1–12.5) years. The PASS threshold was 47.5 (area under curve (AUC) 0.71 (0.45–0.97)) for the HHS, 69.5 (AUC 0.97 (0.92–1.0)) for the KSS knee and 62.5 (AUC 0.81 (0.61–0.99)) for the KSS function. Thirteen patients (29%) had complications, nine of whom required another surgery (20%). The most frequent were Henderson type 1 (soft tissue lesions, n = 5/44 [11%]) and type 2 (loosening, n = 5/44 [11%]) There was no relationship between satisfaction and postoperative complications (p = 0.071). DiscussionMost of the patients who undergo femoral resection and reconstruction (59%) are satisfied with their function, albeit reduced, despite a high complication rate (29%). Our hypothesis is confirmed for the PASS threshold for the HHS (47.5 versus 93) and the KSS knee and function (69.5 and 62.5 versus 85.5 and 72.5). Level of evidenceIV; retrospective observational single-center study.

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

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. To establish the PASS for the ATRS in a Swedish population. Cross-sectional study; Level of evidence, 3. 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. 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. The estimated PASS for the ATRS was 75 in the general Swedish population at 12 to 27 months after an acute Achilles tendon rupture.

Outcomes of primary arthroscopic shoulder stabilization in active patients over 40—results at a mean follow-up of 7 years

PurposeThe purpose of this study is to report clinical outcomes, return to activity, redislocation rate, and rate of conversion to arthroplasty for active patients over age 40 undergoing primary arthroscopic shoulder stabilization. MethodsPatients over 40 years of age who underwent arthroscopic capsulolabral repair for shoulder instability between December 2005 and January 2018 with a minimum of 2-year postoperative follow-up were enrolled in this retrospective, monocentric study. Clinical outcome scores including the 12-Item Short Form Survey (SF-12), American Shoulder and Elbow Surgeons (ASES), Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH), Single Assessment Numeric Evaluation (SANE), and VAS pain were collected. Additionally, it was determined which patients reached the minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS) for the ASES score. Bivariate analysis was utilized to determine if there was any association between baseline demographic and clinical factors with the outcome scores. ResultsOf a total of 814 patients assessed for eligibility, a total of 40 patients were included and 33 patients (8 females) were available for follow-up. Average age was 49.4 ± 7.6 years. At an average follow-up of 7.0 ± 3.6 years, all the outcome scores significantly improved compared to baseline. These include ASES (69.9 ± 19 to 95.8 ± 7.6, p<.001), QuickDASH (29.7 ± 17.7 to 3.9 ± 5.4, p<.002); SANE (53.5 ± 29.3 to 91.6 ± 14.3, p<.003), SF-12 (45.6± 8.8 to 55.2 ± 5.7, p<.001) and VAS (2.1 ± 2.1 to 0.3 ± 1, p<.002). MCID was reached by 72.7% of the patients and 81.8% reached the PASS threshold for the ASES score. Postoperative shoulder stability improved substantially and significantly. Median postoperative satisfaction was 10/10 (range 1-10). 95.6% of the patients returned to sport, with 91.0% of the patients able to return to pre-injury level. One patient (3%) underwent revision surgery for osteoarthritis, in the form of comprehensive arthroscopic management procedure. The presence of cartilage defects cartilage defects Outerbridge grade >2 (p=0.020) and posterior labral lesions (p=0.03) at index surgery were significantly associated with inferior outcomes in the ASES score. ConclusionActive patients aged 40 years and older undergoing arthroscopic shoulder stabilization experienced favorable functional outcomes at a mean follow-up of 7 years, with low rates of revision surgery or of progression to clinically relevant osteoarthritis. However, the presence of high-grade cartilage lesions and the presence of a posterior labral tear were associated with inferior clinical outcomes.

Defining the Patient Acceptable Symptom State (PASS) for PROMIS After Total Ankle Replacement.

Although patient-reported outcomes (PROs), such as the Patient-Reported Outcomes Measurement Information System (PROMIS), are a key element of evaluating success after total ankle replacement (TAR), many do not explicitly state a key factor of postoperative success: is the patient satisfied with their outcome after TAR? The patient acceptable symptom state (PASS) represents the symptom threshold beyond which patients consider themselves well. This study aimed to establish the PROMIS thresholds for the PASS in a primary cohort of TAR patients. This single-institution study included 127 primary TAR patients with preoperative and 2-year postoperative PROMIS scores. At 2 years postoperatively, patients answered 2 PASS anchor questions (Satisfaction, Delighted-Terrible scale) with Likert-scale responses. PASS thresholds with 95% confidence intervals (CIs) were calculated from PROMIS scores using an anchor-based method. Using a bootstrapping technique with 1,000 iterations, the Youden index was calculated to determine the best specificity and sensitivity coordinates to maximize their combination. Finally, preoperative variables associated with the likelihood of achieving the PASS were assessed. There was a strong association between PASS thresholds and PROMIS domains, especially Pain Interference (PASS threshold of <56.0, area under the receiver operating characteristic curve [AUC] = 0.940), Pain Intensity (<48.4, AUC = 0.936), and Physical Function (>44.7, AUC = 0.883). The likelihood of achieving the PASS was not affected by age, race, gender, American Society of Anesthesiologists (ASA) class, body mass index, or severity of ankle deformity. Patients with worse preoperative Physical Function and Global Mental Health scores were less likely to meet the PASS threshold for Physical Function postoperatively (p = 0.028 and 0.041). The ability to reach the PASS after TAR was most strongly associated with postoperative PROMIS pain scores. However, PASS thresholds were generally poorer than population means. This demonstrates that patients do not need to reach normal pain or physical function levels to have an acceptable symptom state after TAR. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

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.

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. 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. Cohort study; Level of evidence, 3. 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. 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. 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.

Clinical Significance Thresholds in Primary and Revision Latarjet Procedures With Comparable Outcome Achievements

Background: Given the variability across populations and settings, defining the MCID and the PASS for the Rowe and ASOSS scores and patients undergoing primary and revision Latarjet it is essential to have accurate benchmarks relevant to these groups when interpreting clinical results. Purpose: To determine the minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) thresholds for the visual analog scale (VAS) for pain during sports, Athletic Shoulder Outcome Scoring System (ASOSS), and Rowe scores after primary and revision Latarjet procedures for treatment of shoulder instability. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: Between January 2018 and January 2020, a retrospective review of 149 patients undergoing primary Latarjet (n = 82) and revision Latarjet (n = 67) to treat shoulder instability was performed in a single institution. Patient-reported outcome measures were collected preoperatively and 1 year postoperatively. The delta was defined as the change between the pre- and postoperative scores. Distribution-based and anchored-based approaches were used to estimate the MCID and the PASS, respectively. The optimal cutoff point and the percentage of patients achieving those thresholds were also calculated. Results: The distribution-based MCIDs after primary Latarjet were 1.1, 7.5, and 9.6 for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved the MCID thresholds were 93.9%, 98.7%, and 100% for the VAS, Rowe, and ASOSS scores, respectively. The PASS thresholds after primary Latarjet were ≤1, ≥90, and ≥85 for the VAS, Rowe, and ASOSS scores, respectively. The percentages of patients who achieved PASS thresholds were 82.9%, 89%, and 86.5% for the VAS, Rowe, and ASOSS scores, respectively. The distribution-based MCIDs after revision Latarjet were 0.6, 6.2, and 3.4 for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved MCID thresholds were 89.3%, 100%, and 100% for the VAS, Rowe, and ASOSS scores, respectively. The PASS thresholds were ≤3, ≥87, and ≥86 after revision Latarjet for the VAS, Rowe, and ASOSS scores, respectively. The rates of patients who achieved the PASS thresholds were 88%, 88%, and 91% for the VAS, Rowe, and ASOSS, respectively. Conclusion: This study identified useful values for the MCID and PASS thresholds in VAS, Rowe, and ASOSS scores after primary and revision Latarjet procedures for treating shoulder instability. Most patients achieved MCID and PASS benchmarks, indicating successful primary and revision Latarjet procedure outcomes. These metrics can serve as valuable parameters when analyzing parameters in future studies and have the potential to enhance patient care by optimizing treatment strategies and surgical decision making.

Defining the Patient Acceptable Symptom State Using PROMIS Following Reconstruction of the Progressive Collapsing Foot Deformity

Introduction/Purpose: Although reconstruction of the flexible progressive collapsing foot deformity (PCFD) has been shown to improve patient-reported outcomes (PROs), there is limited data describing postoperative success as defined by patient satisfaction following surgery. Distinct from the minimal clinically important difference (MCID), the patient acceptable symptom state (PASS) is a novel PRO measurement that represents the symptom threshold beyond which patients are satisfied with their postoperative outcome. The primary aim of this study was to use Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores in combination with anchor questions to define PASS thresholds following reconstruction of the flexible PCFD. A secondary aim was to analyze how patient-specific variables and certain PCFD reconstruction procedures may impact the probability of reaching PASS thresholds. Methods: Using data collected from a foot and ankle orthopedic registry at a large academic institution, 109 patients who underwent reconstruction of a flexible PCFD between February 2019 and March 2021, had preoperative and 2-year postoperative PROMIS PF and PI scores, and 2-year postoperative responses to two PASS anchor questions (the delighted-terrible scale and the satisfied scale) were included in the study. Patients who underwent either a double or triple arthrodesis were excluded. Patient responses to the anchor questions were dichotomized and receiver operating characteristic (ROC) curve analyses were performed. Using the Youden Index to balance sensitivity and specificity and maximize the area under the curve (AUC), PASS thresholds with 95% confidence intervals were quantified using 2000 bootstrapped iterations. Lastly, multivariable logistic regressions were performed to analyze the influence of patient demographics, preoperative PROMIS scores, and certain PCFD reconstruction procedures on the probability of reaching the PASS thresholds. Results: The PASS threshold for PROMIS PF was found to be 42.6 using both the delighted-terrible and the satisfied scale and 73.4% of patients (80/109) reached the threshold (both AUCs: 0.91) (Table 1). The PASS thresholds for PROMIS PI defined using the delighted-terrible scale and the satisfied scale were 54.5 (AUC: 0.90) and 57.5 (AUC: 0.91), respectively, with 72.5% of patients (79/109) and 81.7% of patients (89/109) meeting the respective thresholds. Neither patient demographics nor specific PCFD reconstruction procedures affected the probability of meeting the PASS thresholds. However, a lower preoperative PROMIS PF score or a higher preoperative PROMIS PI score significantly decreased the probability of achieving the PASS thresholds. Conclusion: Following reconstruction of the flexible PCFD, PASS thresholds for the PROMIS PF and PI domains were found to be lower and higher, respectively, than population norms. This suggests that patients may be satisfied with the outcome of their surgery despite not returning to the population mean. The probability of achieving the PASS thresholds was influenced by both preoperative PROMIS PF and PI scores but not by patient demographics or certain PCFD reconstruction procedures. In addition to guiding future outcomes research, these results may help foot and ankle surgeons optimize treatment for the flexible PCFD and better manage patient expectations.

Defining the Patient Acceptable Symptom State (PASS) for PROMIS After Hallux Valgus Correction Surgery

Introduction/Purpose: Surgical interventions to correct hallux valgus have been shown to improve patient reported outcomes (PROs); however, many of these instruments do not measure a patient’s subjective outcome experience. The patient acceptable symptom state (PASS) is defined as the symptom threshold that a patient must reach to be satisfied with the outcome of their surgery. PASS thresholds have been defined for hallux valgus correction using American Orthopaedic Foot &amp; Ankle Society (AOFAS) scores; however, no studies have used a validated PRO metric. This is the first study that aims to establish PASS thresholds for Patient-Reported Outcome Measurement Information System (PROMIS) scores in patients following operative intervention for hallux valgus. Methods: A retrospective review of prospectively collected data within an institutional registry was performed. We identified 291 patients treated for hallux valgus with or without second hammertoe correction between February 2019 and March 2021 with at least 2-year post-operative PROMIS scores. Chart review was performed to obtain demographic information and to confirm the surgical procedures completed. Two-years post-operatively, patients answered two PASS anchor questions (Satisfaction, Delighted-Terrible scale) with Likert-scale responses, which was collected along with pre-operative and 2-year post-operative PROMIS scores via the registry. After patient’s answers to the Satisfaction and Delighted-Terrible scales were recategorized into binary responses; PASS thresholds were determined using the maximum Youden Index and a 95% confidence interval was quantified using 2000 bootstrapped iterations. Differences in patient and surgical characteristics between patients who met or did not meet the PASS threshold were compared using independent samples t-test and Pearson chi square. Results: There was excellent association between PASS thresholds and the PROMIS domains of Physical Function (50.3, AUC=0.86) and Pain Interference (51.5, AUC=0.86). Overall, 204/291 and 205/291 patients met the threshold for Physical Function (PF) and Pain Interference (PI), respectively. For both PROMIS domains, a lower BMI was associated with a higher likelihood of meeting the PASS threshold (p=0.002 for PF, p=0.032 for PI). For the PF domain, Lapidus patients were more likely to meet the PASS threshold (p=0.05), and patients with first MTP fusion were less likely to meet the PASS threshold (p=0.004). Meeting the PASS threshold wasn’t impacted by the concomitant correction of a second hammertoe. Lastly, patients with a higher pre-operative PF score had a greater chance of meeting the PASS threshold (p &lt; 0.001). Conclusion: This is the first study to define a PASS threshold for hallux valgus correction using PROMIS scores, a validated outcomes measure. Pre-operative PROMIS scores, patient BMI, and the type of procedure performed impacted a patient’s likelihood of meeting the PASS threshold. These results may be helpful in counseling and educating patients on their chances of obtaining a satisfactory result following hallux valgus correction.

Defining the Patient Acceptable Symptom State (PASS) for PROMIS After Hallux Rigidus Correction Surgery

Introduction/Purpose: In an ever-changing healthcare landscape, patient-reported outcomes (PROs) are becoming more important for reimbursement and evaluating the success of surgical procedures. Unfortunately, it is unclear which PROs correlate best with clinical improvement. The patient acceptable symptom state (PASS) asks the patient whether or not their outcome is acceptable at a particular post-operative time point. Recently, the use of this metric has gained traction within the foot and ankle literature. To our knowledge, this is the first study that aims to establish PASS thresholds for Patient-Reported Outcome Measurement Information System (PROMIS) scores in patients who underwent operative intervention for hallux rigidus. Methods: A retrospective review of prospectively collected data within an institutional registry was performed. We identified 174 patients treated for hallux rigidus between February 2019 and March 2021 with at least 2-year post-operative PROMIS scores. Chart review was performed to obtain demographic information and to confirm the surgical procedures that were completed. Two-years post-operatively, patients answered two PASS anchor questions (Satisfaction, Delighted-Terrible scale) with Likert- scale responses, which was collected along with pre-operative and 2-year post-operative PROMIS scores via the registry. After patient’s answers to the Satisfaction and Delighted-Terrible scales were recategorized into binary responses, PASS thresholds were determined using the maximum Youden Index and a 95% confidence interval was quantified using 2000 bootstrapped iterations. Differences in patient and surgical characteristics between patients who met or did not meet the PASS threshold were compared using independent samples t-test and Pearson chi square. Statistical significance was established at an alpha of 0.05. Results: There was excellent association between PASS thresholds and the PROMIS domains of Physical Function (48.6, AUC=0.82) and Pain Interference (52.1, AUC =0.86). Overall, 125/174 (71.8%) and 105/174 (60.3%) patients met the threshold for Physical Function (PF) and Pain Interference (PI), respectively. For the PF and PI domains, age, BMI, method of cheilectomy and use of Akin/Moberg osteotomy did not impact a patient’s likelihood of meeting the PASS threshold. For the PF domain and the PI domain stratified by the Delighted-Terrible scale, women were more likely to meet the PASS threshold than men (63.2% vs. 36.8%, p = 0.057 and 73% vs. 45%, p =0.023, respectively). Lastly, patients with a higher pre-operative PF score had a higher chance of meeting the PASS threshold (p &lt; 0.001). Conclusion: Following operative intervention to treat hallux rigidus, pre-operative PROMIS scores were strongly associated with a patient’s likelihood of meeting the PASS threshold. After surgical intervention for hallux rigidus, less than 75% of the patients felt their outcome was acceptable; however, the PASS threshold for PF was lower than population average, so it may not be necessary for patients to reach normal physical function levels post-operatively in order to have an acceptable outcome.

Defining the patient acceptable symptom state using PROMIS following reconstruction of the progressive collapsing foot deformity

BackgroundThe patient acceptable symptom state (PASS) represents the threshold beyond which patients are satisfied with their outcome. This study aimed to define PASS thresholds for progressive collapsing foot deformity (PCFD) reconstruction using Patient-Reported Outcomes Measurement Information System (PROMIS) scores and anchor question responses. MethodsThis retrospective study consisted of 109 patients who underwent flexible PCFD reconstruction, had preoperative and 2-year postoperative PROMIS scores, and 2-year postoperative anchor question responses. ROC curve analyses were performed to quantify PASS thresholds. ResultsPASS thresholds for the PROMIS Physical Function (PF) and Pain Interference (PI) domains were found to be lower and higher, respectively, than population norms. Furthermore, patients with higher preoperative PROMIS PF scores or lower preoperative PROMIS PI scores had a significantly higher likelihood of achieving the PASS thresholds. ConclusionIn addition to guiding future outcomes research, these results may help surgeons optimize treatment for PCFD and better manage patient expectations. Level of evidenceIII, retrospective cohort study

Quadriceps Tendon Autograft ACL Reconstruction With Suture Tape Augmentation: Safe Results Based on Minimum 2-Year Follow-up MRI.

The potential intra-articular effects of ≥1 year after anterior cruciate ligament reconstruction (ACLR) with independent suture tape augmentation (STA) are not fully understood. To investigate whether incorporating suture tape in an all-soft tissue quadriceps tendon autograft (QTA) ACLR leads to satisfactory patient outcomes while having no intra-articular side effects as determined by magnetic resonance imaging (MRI). Case series; Level of evidence, 4. Included were 25 patients with a mean age of 19.9 years (95% CI, 17.3-22.5 years) who underwent QTA ACLR with STA between 2016 and 2019. All patients underwent MRI at ≥1 year postoperatively and had at least a 2-year follow-up (mean, 28 months [95% CI, 26.5-29.5 months]) that included physical examination with anterior laxity testing with KT-1000 arthrometer, radiographs, and patient-reported outcome measures (PROMs). At the final follow-up, the minimal clinically important difference (MCID) and the Patient Acceptable Symptom State (PASS) for applicable PROMs were applied to each patient. Postoperative graft and joint integrity were assessed using the Howell classification and the MRI Osteoarthritis Knee Score (MOAKS) joint effusion/synovitis grade. The Mann-Whitney U test for continuous variables and the chi-square or the Fisher exact test for categorical variables were used for statistical analyses. The MRI assessment of the grafts demonstrated intact grafts in all patients. Overall, 96% of patients demonstrated grades 0 or 1 MOAKS for joint effusion/synovitis. All patient outcomes significantly improved from preoperatively to the final follow-up (P < .001), except for the Marx score, which decreased significantly (14.2 [95% CI, 12.7-15.8] vs 9.72 [95% CI, 7.3-12.2]; P = .0014). At least 68% of the patients achieved the MCID threshold, and 92% achieved the PASS threshold for all applicable PROMs. QTA ACLR with STA did not demonstrate adverse intra-articular changes on MRI at ≥1 year postoperatively. In addition, STA did not appear to negatively affect PROMs.

Establishing the Patient Acceptable Symptom State Thresholds for Patient-Reported Outcomes after Operatively Treated Tibial Plateau Fractures.

Define patient-acceptable symptom state (PASS) thresholds and factors affecting PASS thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Knee Injury and Osteoarthritis Outcome Score (KOOS) following operatively treated tibial plateau fractures. Retrospective cohort. Single Level I academic trauma center. All patients (n = 159) who underwent fixation of a tibial plateau fracture from 2016 to 2021 and completed patient-reported outcome measures (PROMs) at minimum 1-year follow-up were enrolled for the study. PASS thresholds for global outcome (PASS-Global), pain (PASS-Pain), and function (PASS-Function) were determined using anchor-based questions such as "How satisfied are you today with your injured lower extremity?" with answer choices of very satisfied, satisfied, neutral, unsatisfied, and very unsatisfied. PASS thresholds for each PROM were calculated using 3 methods: (1) 80% specificity, (2) 75th percentile, and (3) Youden Index. Sixty percent of patients were satisfied with their global outcome and 53% with function. Using 80% specificity, 75th percentile, and Youden Index, PASS-Global thresholds were 48.5, 44.5, and 47.9 for PROMIS-PF and 56.3, 56.2, and 56.3 for KOOS-QOL, respectively. PASS-Pain threshold for KOOS-Pain was 84.4, 80.6, and 80.6, respectively. PASS-Function thresholds were 48.9, 46.8, and 48 for PROMIS-PF and 94.1, 90.2, and 86.8 for KOOS-ADL, respectively. Younger patients and those with bicondylar fractures or infections were associated with significantly lower PASS-Pain thresholds. Schatzker II fractures, lateral column involvement, or isolated lateral approach resulted in significantly higher PASS-Global and PASS-Function thresholds. This study defines global, functional, and pain PASS thresholds for tibial plateau fractures. Patients with bicondylar fractures, infections, and medial column involvement were more often unsatisfied. These thresholds are valuable references to identify patients who have attained satisfactory outcomes and to counsel patients with risk factors for unsatisfactory outcomes following tibial plateau fractures. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Diagnosis-Specific Thresholds of the Minimal Clinically Important Difference and Patient Acceptable Symptom State for KOOS After Total Knee Arthroplasty.

This article was updated on May 1, 2024 because of a previous error, which was discovered after the preliminary version of the article was posted online. The byline that had read "Ahmed K. Emara, MD 1 *, Ignacio Pasqualini, MD 1 *, Alison K. Klika, MS 1 , Melissa N. Orr, BS 1 , Pedro J. Rullán, MD 1 , Nicolas S. Piuzzi, MD 1 , and the Cleveland Clinic Arthroplasty Group†" now reads "Ahmed K. Emara, MD 1 *, Ignacio Pasqualini, MD 1 *, Yuxuan Jin, MS 1 , Alison K. Klika, MS 1 , Melissa N. Orr, BS 1 , Pedro J. Rullán, MD 1 , Nicolas S. Piuzzi, MD 1 , and the Cleveland Clinic Arthroplasty Group†". Literature-reported minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds for patient-reported outcome measures demonstrate marked variability. The purpose of this study was to determine the minimal detectable change (MDC), MCID, and PASS thresholds for the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subdomain, Physical Function Short Form (PS), and Joint Replacement (JR) among patients with osteoarthritis (OA) who underwent primary total knee arthroplasty (TKA). A prospective cohort of 6,778 patients who underwent primary TKA was analyzed. Overall, 1-year follow-up was completed by 5,316 patients for the KOOS Pain, 5,018 patients for the KOOS PS, and 4,033 patients for the KOOS JR. A total of 5,186 patients had an OA diagnosis; this group had an average age of 67.0 years and was 59.9% female and 80.4% White. Diagnosis-specific MDCs and MCIDs were estimated with use of a distribution-based approach. PASS values were estimated with use of an anchor-based approach, which corresponded to a response to a satisfaction question at 1 year postoperatively. The MCID thresholds for the OA group were 7.9 for the KOOS Pain, 8.0 for the KOOS PS, and 6.7 for the KOOS JR. A high percentage of patients achieved the MCID threshold for each outcome measure (KOOS Pain, 95%; KOOS PS, 88%; and KOOS JR, 94%). The MDC 80% to 95% confidence intervals ranged from 9.1 to 14.0 for the KOOS Pain, 9.2 to 14.1 for the KOOS PS, and 7.7 to 11.8 for the KOOS JR. The PASS thresholds for the OA group were 77.7 for the KOOS Pain (achieved by 73% of patients), 70.3 for the KOOS PS (achieved by 68% of patients), and 70.7 for the KOOS JR (achieved by 70% of patients). The present study provided useful MCID, MDC, and PASS thresholds for the KOOS Pain, PS, and JR for patients with OA. The diagnosis-specific metrics established herein can serve as benchmarks for clinically meaningful postoperative improvement. Future research and quality assessments should utilize these OA-specific thresholds when evaluating outcomes following TKA. Doing so will enable more accurate determinations of operative success and improvements in patient-centered care. Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.

The Promising 2-Year Performance of the Patient-Reported Outcomes Measurement Information System in Primary Hip Arthroscopy for Femoroacetabular Impingement Syndrome

Background: Minimal clinically important difference (MCID) and patient acceptable symptom state (PASS) thresholds have been previously defined for the Patient-Reported Outcomes Measurement Information System (PROMIS) at 1-year follow-up in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome; however, the MCID and PASS thresholds are yet to be defined for the PROMIS at 2-year follow-up. Purpose: (1) To establish MCID and PASS thresholds for the PROMIS Pain Interference (PROMIS-PI) and PROMIS Physical Function (PROMIS-PF) at 2-year follow-up and (2) to correlate PROMIS scores with hip-specific patient-reported outcome measure (PROM) scores. Study Design: Cohort study (diagnosis); Level of evidence, 3. Methods: Patients undergoing primary hip arthroscopy for femoroacetabular impingement syndrome between August and November 2020 with preoperative and minimum 2-year postoperative data were identified. Collected scores included those for the PROMIS-PI, PROMIS-PF, Hip Outcome Score–Activities of Daily Living (HOS-ADL), Hip Outcome Score–Sports Subscale (HOS-SS), International Hip Outcome Tool–12 (iHOT-12), and visual analog scale (VAS) for pain. MCID thresholds were calculated using the distribution-based method and PASS thresholds using the anchor-based method. Pearson correlation coefficients were used to compare scores between PROMs. Results: A total of 65 patients met the criteria for inclusion (72.3% female; mean age, 36.9 ± 13.5 years; mean body mass index, 26.2 ± 6.0). The mean follow-up was 25.3 ± 3.3 months. Significant preoperative to postoperative improvements were observed for all PROMs (P < .001). MCID thresholds and achievement rates were as follows: HOS-ADL, 10.1 and 75%, respectively; HOS-SS, 13.8 and 79%, respectively; iHOT-12, 14.0 and 67%, respectively; VAS pain, –13.8 and 78%, respectively; PROMIS-PI, –4.7 and 65%, respectively; and PROMIS-PF, 5.8 and 60%, respectively. PASS thresholds and achievement rates were as follows: HOS-ADL, 78.7 and 67%, respectively; HOS-SS, 76.4 and 62%, respectively; iHOT-12, 67.4 and 60%, respectively; VAS pain, 25.5 and 61%, respectively; PROMIS-PI, 57.0 and 65%, respectively; and PROMIS-PF, 45.6 and 58%, respectively. PROMIS-PI scores correlated most strongly with HOS-ADL (r = −0.836), HOS-SS (r = −0.767), and iHOT-12 (r = −0.719) scores and exhibited at least moderate correlations (r≥−0.595) with the other PROM scores. PROMIS-PF demonstrated moderate correlations with all the other PROM scores (r≥−0.586). Strong correlations were seen between the hip-specific PROM scores (r≥−0.745). Conclusion: This study defined 2-year MCID and PASS thresholds for the PROMIS-PI and PROMIS-PF and demonstrated moderate to strong correlations between PROMIS scores and hip-specific PROM scores.

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?

BackgroundThis 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. MethodsA 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. ResultsThe 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. ConclusionsWhile 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.