Baseline Patient-reported Outcomes Research Articles

Risk factors for extended hospital stay following minimally invasive transforaminal lumbar interbody fusion

BackgroundPrior literature has examined predictors of length of stay (LOS) for lumbar fusion broadly, grouping multiple surgical approaches into one sample. Evaluating minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) specifically can reduce variability introduced by other approaches to effectively identify predictors of LOS. The purpose of this study is to evaluate preoperative predictors of extended LOS in patients undergoing MIS-TLIF. MethodsMIS-TLIF patients were identified from a spine surgeon’s database. Preoperative predictors of LOS, including demographics, comorbidity data, spinal pathology, patient-reported back pain, leg pain, physical function, disability, general physical health, mental health, and depressive burden scores were analyzed. Univariate analysis was performed to identify predictors of LOS ≥ 48 and LOS ≥ 72 h, a multivariate analysis confirmed significance. Eight-hundred-one patients were included. ResultsAfrican-American patients were 4.3 times more likely to have a LOS≥48 h compared to Caucasians (p ≤ 0.001). Diagnosis of herniated nucleus pulposus and foraminal stenosis were negative predictors of an LOS ≥ 72 h (p ≤ 0.014, both). Self-identified African American patients were approximately twice as likely to have a LOS ≥ 72 h compared to Caucasians. Preoperative Oswestry Disability Index (ODI) was positively correlated with LOS ≥ 48 h (p = 0.008). Other baseline patient-reported outcomes (PROs) were not predictive of LOS ≥ 48 or 72 h (p > 0.050, all). ConclusionsFurther research should explore why different demographic characteristics may be associated with extended postoperative LOS to target interventions toward potential health disparities. Understanding preoperative risk factors can help target increased healthcare costs and improve patient care through tailored interventions and future research.

Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

108 Background: EV+P nearly doubled median progression-free survival and overall survival vs PBC in patients (pts) with previously untreated la/mUC in the phase 3 EV-302 trial. PROs are reported here. Methods: In EV-302 (NCT04223856) pts were randomized 1:1 to EV+P or PBC (gemcitabine with cisplatin or carboplatin). PRO assessments included the EORTC Quality of Life Questionnaire (EORTC QLQ-C30), and the Brief Pain Inventory Short Form (BPI-SF) completed at baseline, weekly for 12 weeks (wks), then every 3 wks through survival follow-up, inclusive of the time post-progression. Time to pain progression (TTPP) and mean change from baseline in worst pain at wk 26 using the BPI-SF were prespecified analyses statistically tested using a gatekeeping strategy. Mean change from baseline through wk 26 and time to confirmed deterioration (TTCD) of EORTC-QLQ-C30 and BPI-SF domains were prespecified descriptive analyses. TTPP and TTCD were assessed using Kaplan-Meier methods. Results: Of 886 pts randomized, 731 (376 received EV+P; 355 PBC) completed baseline PRO questionnaires. Compliance rates differed between arms and remained >70% through wk 29 for EV+P and through only wk 17 for PBC. Median TTPP was 14.2 months (mos) with EV+P and 10.0 mos with PBC (hazard ratio [HR]=0.92; 95% CI=0.72, 1.17; 2-sided p-value=0.48). The least squares (LS) mean reduction in worst pain at wk 26 was numerically greater with EV+P vs PBC (-0.61 vs -0.03, LS mean difference [95% CI]: -0.58 [-1.05, -0.11] [nominal 2-sided P = 0.015]). Pts with moderate to severe pain at baseline who were treated with EV+P (n=128, 34%) had a meaningful (>2 pt) improvement from baseline in BPI worst pain from wk 3 through 26. In EORTC QLQ-C30 Global Health Status/Quality of Life [GHS/QoL], EV+P demonstrated a transient worsening at week 3 (-6.3) that returned to baseline from weeks 4 through 26, while patients treated with PBC demonstrated deterioration from week 1 through week 17 (range -1.2 to -7.1) where scores returned to baseline. TTCD for EORTC QLQ-C30 GHS/QoL was 5.9 mos with EV+P vs 3.2 mos with PBC (HR = 0.98 [95% CI]: 0.79 – 1.2). Conclusions: Pts treated with EV+P have improved survival compared with PBC without detriment to quality of life and functioning, further supporting the value of EV+P for pts with la/mUC. Compliance, especially after progression, was lower than expected (particularly in the PBC arm) and may have impacted the results. Clinical trial information: NCT04223856 .

PCL Preservation vs. PCL Sacrifice: Comparing Patient Outcomes in Medial Congruent Total Knee Arthroplasty.

The aim of this study was to compare outcomes and complication rates between posterior cruciate ligament (PCL) retention and excision utilizing a medial congruent (MC) polyethylene insert in total knee arthroplasty (TKA) in a specialized ambulatory surgery center (ASC) dedicated to hip and knee arthroplasty. A retrospective review was performed between May 2023 and October 2023 analyzing 398 patients who underwent primary MC TKA by high-volume joint arthroplasty surgeons (n=9) with either PCL preservation (n=264) or sacrifice (n=134) in a single free-standing ASC. Patients were matched chronologically on a 2:1 basis. Demographics, baseline function, 90 day complications, and patient reported outcomes were recorded for each patient. There were no differences in pre-op baseline function or patient-reported outcome measures (PROMs), Charlson Comorbidity Index (COI), or American Society of Anesthesiologists (ASA) class amongst patient groups. The PCL-preserve and PCL-sacrifice cohorts showed significant variation in 12 week post-op Knee injury and Osteoarthritis Outcome, Junior (KOOS, JR.) scores. Specifically, the number of patients who achieved the minimal clinically important difference (MCID) in KOOS, JR. scores was higher in the PCL-sacrifice group (p<0.05). Yet, no complications within the 90 day period were associated with PCL status and other patient-reported outcomes. This manuscript comparing outcomes between MC TKAs with PCL retention and sacrifice suggests that both techniques are viable options with similar functional outcomes, pain scores and complication rates which may have benefits in an ASC setting. The PCL-sacrifice group exhibited a statistically significant increase in patients who achieved the MCID in KOOS, JR. score compared to the PCL-preserving at early follow up. Future research should employ prospective, randomized designs to further validate these findings and explore long-term implications.

A Comparison of Clinical Outcomes Between Anterior Cervical Discectomy and Fusion Versus Posterior Cervical Laminoplasty for Multilevel Cervical Myelopathy.

Retrospective Cohort. To compare patient-reported outcomes and surgical outcomes after anterior cervical discectomy and fusion (ACDF) versus cervical laminoplasty for multilevel cervical spondylotic myelopathy. Treatment options for multilevel cervical spondylotic myelopathy include ACDF and cervical laminoplasty. Given that the literature has been mixed regarding the optimal approach, especially in patients without kyphosis, there is a need for additional studies investigating outcomes between ACDF and cervical laminoplasty. A retrospective review was conducted of adult patients undergoing 3 or 4-level surgery. Patients with preoperative kyphosis based on C2-C7 Cobb angles were excluded. The electronic medical record and institutional databases were reviewed for baseline characteristics, surgical outcomes, and patient-reported outcomes. A total of 101 patients who underwent ACDF and 52 patients who underwent laminoplasty were included in the study. The laminoplasty cohort had a higher overall Charlson Comorbidity Index (3.10 ± 1.43 vs 2.39 ± 1.57, P = 0.011). Both groups had a comparable number of levels decompressed, C2-C7 lordosis, and diagnosis of myelopathy versus myeloradiculopathy. Patients who underwent laminoplasty had a longer length of stay (2.04 ± 1.15 vs 1.48 ± 0.70, P = 0.003) but readmission, complication, and revision rates were similar. Both groups had similar improvement in myelopathy scores (∆modified Japanese Orthopedic Association: 1.11 ± 3.09 vs 1.06 ± 3.37, P = 0.639). ACDF had greater improvement in Neck Disability Index (∆Neck Disability Index: -11.66 ± 19.2 vs -1.13 ± 11.2, P < 0.001), neck pain (∆Visual Analog Scale-neck: -2.69 ± 2.78 vs -0.83 ± 2.55, P = 0.003), and arm pain (∆Visual Analog Scale-arm: -2.47 ± 3.15 vs -0.48 ± 3.19, P = 0.010). These findings persisted in multivariate analysis except for Neck Disability Index. ACDF and cervical laminoplasty appear equally efficacious at halting myelopathic progression. However, patients who underwent ACDF had greater improvements in arm pain at 1 year postoperatively. Longitudinal studies evaluating the efficacy of laminoplasty to mitigate adjacent segment disease are indicated to establish a robust risk-benefit assessment for these 2 procedures. III.

Does Baseline Facet Arthropathy Influence Early Clinical and Radiographic Outcomes After Cervical Disc Replacement?

Severe facet arthropathy is generally a contraindication to undergoing cervical disc replacement (CDR) due to associated instability and potentially limited improvement in neck pain caused by arthropathy. This study evaluates the influence of facet arthropathy on radiographic/early clinical outcomes after CDR. One/two-level CDR patients from a single surgeon's prospectively maintained database created 2 cohorts based on facet arthropathy: grade 0-1 or 2-3 (milder/moderate arthropathy). Patient-reported outcome measures for neck disability, neck/arm pain, depressive burden, mental/physical health/function were obtained preoperatively and through final follow-up (average follow-up: 8.5 ± 6.5 months). Preoperative/postoperative radiographs measured segmental lordosis and C2-C7/segmental range of motion (ROM) and determined facet grade for each operative level. Demographic differences, perioperative variables, baseline patient-reported outcomes, and intercohort differences/changes for postoperative patient-reported/radiographic outcomes were determined. Of 161 patients, 100 were in the milder arthropathy group. There were no differences in baseline patient-reported outcomes. Patients with moderate arthropathy reported superior 6-week 12-Item Veterans Rand Mental/Physical Composite Scores (P ≤ .047, all). By final follow-up, moderate patients reported better 12-Item Veterans Rand Mental/Physical Composite Scores/Patient-Reported Outcome Measurement Information System-Physical Function/Patient-Health Questionnaire-9 (P ≤ .049, all). Cohorts reported similar improvements in all patient-reported outcomes by 6 weeks/final follow-up. Those with more severe facet arthropathy had significantly shorter preoperative disc heights (P < .001). Accounting for baseline disc height differences, by final follow-up, moderate patients had lower segmental ROM (P = .036). There were no significant differences in radiographic measurement changes (P ≥ .264, all). Postoperatively, patients with moderate facet arthropathy reported lower depressive burden, better mental health/physical function, and lower segmental ROM. However, this did not translate to inferior short-term clinical outcomes. Further study should be conducted on the relationship between clinical/radiographic outcomes in CDR patients with facet arthropathy.

Change in financial toxicity during early-phase cancer clinical trial (EP-CT) participation.

11119 Background: The high costs of care (financial toxicity) represent a pressing concern in oncology. Little is known about the financial toxicity experienced by EP-CT participants. We sought to describe changes in financial toxicity during EP-CTs and assess associations of change in toxicity with patient characteristics, additional patient-reported outcomes (PROs), and trial reimbursement structure. Methods: We prospectively enrolled adults participating in EP-CTs from 4/2021 – 1/2023. We administered surveys at baseline (between enrollment and Day 1 of trial) and monthly during trial participation. We assessed financial toxicity using the COST tool, graded as low (≥26) and high (0–25) toxicity. We also surveyed baseline hope (Hope Herth Index), quality of life (QOL; FACT-G) and symptom burden (psychological: PHQ-4; physical: ESAS). We calculated within-patient changes in COST score and conducted linear mixed models, controlling for baseline COST score, to determine associations of change in financial toxicity with patient characteristics, baseline PROs, and trial reimbursement structure (using a factor x time interaction term). Results: Of 221 eligible patients, we enrolled 205 (median age = 63.3 years [range 32.8-88.6], 57.1% female). Most common tumors were GI (34.6%) and breast (20.0%). At trial start, 35.0% of patients reported high financial toxicity, 40.5% at 1 month, 33.6% at 2 months, 25.5% at 6 months, and 40.0% at 1 year. Within-patient COST score worsened over time (B=-0.20, p=0.059), although this change did not reach significance. We found no patient characteristics that significantly correlated with change in COST score, including age (B=-0.005, p=0.602), sex (B=-0.097, p=0.667), GI cancer (B=-0.11, p=0.118), annual income &gt;$60,000 (B=-0.10, p=0.306), and current employment (B=-0.34, p=0.121). Higher baseline QOL was associated with increased COST score (financial wellbeing, while on trial (B=0.012, p=0.011); there was no significant association with other baseline PROs. Most patients (64.4%) enrolled on trials that offered reimbursement for study costs. Of those offering reimbursement, 40.1% had all research-specific costs reimbursed. There was no significant association between change in COST score and presence of any reimbursement (B=0.12, p=0.614) or presence of full reimbursement (B=-0.072, p=0.784). Conclusions: In this cohort of EP-CT participants, over one-third reported high rates of financial toxicity, which appeared relatively stable over time on trial. We did not identify any demographic factors associated with risk of worsening toxicity but did find that high baseline QOL may be protective. Trial reimbursement did not lead to improvement in financial wellbeing. Findings demonstrate that EP-CT participation may not place excess financial burden on at-risk patients and highlight the need to monitor for financial toxicity across all trial participants.

A descriptive patient-reported outcomes (PROs) analysis of KEYNOTE-412 to understand head and neck symptom burden.

11116 Background: The randomized, double-blind, phase 3 KEYNOTE-412 study (NCT03040999) investigated pembrolizumab (pembro) + chemoradiation therapy (CRT) versus placebo + CRT for locally advanced head and neck squamous cell carcinoma (LA HNSCC). Descriptive PRO analysis may provide important insight to better understand patient (pt) experiences. This analysis evaluated pt experience by examining item-level PRO scores. Methods: Adults with LA HNSCC were randomly assigned 1:1 to pembro 200 mg IV Q3W or placebo + CRT. PROs included the EORTC QLQ-C30 and EORTC QLQ-H&amp;N35. Responses to each item of the QLQ-C30 and H&amp;N35 were analyzed descriptively based on treatment group combined data. Each item was evaluated overall, and then for the H&amp;N35 by tumor location and by clinical event (death, distant progressive disease [PD], local regional PD, local PD, and distant metastasis or histologically persistent/residual disease). Symptom burden was defined as responses of “a little,” “quite a bit,” “very much,” or “yes.” Items associated with high symptom burden (≥30% of responses “quite a bit,” “very much,” or “yes”) at baseline were analyzed over time. Results: Of 756 pts with PRO data, highly endorsed items (≥50% experiencing the symptom) on the QLQ-C30 at baseline were pain, trouble sleeping, needing rest, tiredness, and worry; highly endorsed (≥50%) items from the H&amp;N35 were pain in mouth, painful throat, problems swallowing solid food, coughing, hoarseness, and use of pain killers. Pts with an event, compared to pts who were event-free at the time of data cut-off, experienced greater symptom burden at baseline; for example, pain in mouth (56% vs 50%), pain in jaw (47% vs 37%), use of pain killers (71% vs 58%), weight loss (53% vs 30%), trouble eating (63% vs 46%), and problems swallowing solid food (69% vs 56%). Symptoms at baseline also differed by primary tumor location, demonstrating the heterogeneity of symptom burden across this population. Based on the threshold of ≥30% reporting worse responses at baseline, 20 items on the H&amp;N35 were analyzed over time. Of pts who experienced an event (n = 345, 46%), 6 items met this threshold: pain in mouth (32%), problems swallowing solid food (41%), trouble eating (32%), use of pain killers (71%), use of nutritional supplements (34%), and weight loss (53%). For these items, a similar or greater percentage of pts with symptoms were observed over time in those who had events compared to those with no events. Conclusions: Observations of pts enrolled in KEYNOTE-412 study who had events, appearing to have greater symptom burden at baseline, suggests there may be a relationship between baseline item scores and clinical outcomes. Heterogeneity of populations may lead to variability of baseline PRO scores and should be considered in PRO analysis. Further research is needed to explore the relationship between baseline PROs and event outcomes as well as additional subgroup analysis. Clinical trial information: NCT03040999 .

Evidence to support ePRO-based patient care in survivorship for outpatient with advanced upper gastrointestinal cancer.

e13789 Background: The patients with advanced upper gastrointestinal (UGI) cancer reported multiple symptom burdens at diagnosis and after failing multiple chemotherapy lines. Assessing the readiness of patient-reported outcome (PRO) parameters to support evidence-based pathways for monitoring and managing outpatients is an unmet clinical need to integrate PRO into routine outpatient care for UGI cancer patients. This study aims to identify the most relevant PRO parameters that represent the high symptom burden and functioning impairment overtime during chemotherapy for advanced UGI cancer. Methods: Eligible UGI adult cancer patients (N=111) for a new line of chemotherapy were enrolled. Multiple symptoms were assessed electronically for 36 weeks, using The M.D. Anderson Symptom Inventory GI module (MDASI-GI). Longitudinal symptoms burden was analyzed using mixed-effect models adjusted for age, sex, performance status (PS) (good vs. poor PS ( ECOG 0-1 vs. 2-4). Results: Patients who contributed with more than baseline PROs were included in the analysis (n=92). Of those patients, 43 were treatment-naïve, and 49 had received prior therapy. The primary tumor sites include esophageal (32%), gastroesophageal junction (GEJ) (25%), or gastric (40%). All patients at baseline reported the following symptoms at a severe level (score ≥7 on a 0-10 MDASI-GI scale): fatigue, lack of appetite, pain, disturbed sleep, drowsy, and inability to eat. There was no significant difference in the composite score of these symptoms overtime, regardless of disease groups or treatment status at baseline. Patients with poor PS reported a statistically significant severe composite score baseline ( P=.04). Patients who stayed longer in the study during their survivorship reported a decreased prevalence of moderate to severe symptoms (score of ≥ 4) from 51% at baseline to 40% at 12 weeks, 34% at 24 weeks, and to 28% at 36 weeks. Over time, treatment naïve patients had more severe numbness/tingling, while previously treated group had more severe distress. Conclusions: This longitudinal prospective study during survivorship in patients undergoing chemotherapy for advanced UGI cancer provides a set of most distressing symptom burdens that need to be monitored as part of outpatient care. These data support establishing symptom management pathways for routine use of ePRO for screening and triage of, and linking those symptoms to toxicities after chemotherapy for UGI cancer patients.

Health resource utilization expenditures in oncology within a virtual primary cancer survivor care clinic.

e13785 Background: Unprecedented cancer treatment efficacy has led to high rates of disease sequelae. Lancet recently declared the failure to care for the human dimensions of cancer treatment a "humanitarian crisis." To address this humanitarian crisis, real-world economic evidence can improve patient access to whole person care through insurance reimbursement policies. Methods: We implemented a virtual primary cancer survivor care clinic that follows ASCO and NCCN guidelines for cancer survivors with emphasis on mental health, nutrition, physical activity, and sleep optimization. Our clinic utilizes medical oncologists, physician associates, mental health therapists, registered dietitians, and occupational therapists. Patient reported outcomes (PRO) monitor health status and inform treatment pathways. To reduce test fatigue, we use the SF12 Vitality Enhanced scale (SF12v2). The SF12v2 measures physical functioning, activities of daily living, pain, vitality, social functioning, and mental health. Total medical expenditures (MEs) is the sum of payments for hospital inpatient events, emergency room visits, home care, prescribed medicines, office-based and out-patient visits, and medical equipment. Patient SF12v2 summary scores predict a patient's total MEs. A one-point better physical component summary score and mental component summary score are associated with 2% lower MEs; 3 and 5 point score increases are associated with 10% and 18% lower MEs. Results: Patients were referred from a Utah community oncology clinic, other medical clinics, or self-referred (N=99). The mean patient age was 52 years. 84% were female, 16% were male. At enrollment, 35% had started treatment, 21% were on post treatment aromatase therapy or adjuvant hormonal therapy, 65% were post treatment. Baseline PRO reveal significant disease burden: 82% report poor mental health; 72% report poor physical health; 79% report poor cognitive health; 83% report sleep disorders. For patients who completed at least three PRO measurement time points (n=54): 91% had a positive clinical outcome for mental health; 70% had a positive clinical outcome for physical health; 89% had a positive clinical outcome for cognitive health; 76% had a positive clinical outcome for sleep health. As a result of these extraordinary outcomes, 74% of patients had lower predicted MEs. The average predicted reduction in MEs was 16% with an average annual savings of $1,629.49. Conclusions: Cancer is associated with high disease sequelae and high MEs. We believe this is the first study that reports real-world clinical evidence and predicts MEs for patients enrolled in a virtual primary cancer survivor care clinic. Real-world evidence demonstrates both clinically significant improvements in HRQoL and reductions in patient MEs. These results can inform insurance reimbursement policies, ensuring equitable access to cancer survivor care.

Patient-reported symptom interference with activity- and mood-related functioning prior to start of an early-phase oncology combination trial including immune checkpoint blockade.

12084 Background: We examined symptom interference with activity- and mood-related functioning at baseline in early-stage trials of combination treatments that included at least one immune checkpoint inhibitor, and its association with quality of life (QOL)-, clinical-, and trial-related factors. Methods: Patients scheduled to begin an early-phase trial of a combination treatment with immune checkpoint blockade, and who had not received trial-related treatment were recruited into a prospective longitudinal study design (NCI R01CA242565), and completed the following validated patient-reported outcome (PRO) measures prior to trial start: MD Anderson Symptom Inventory- Immunotherapy (score range: 0-10, higher scores = worse symptom interference); NCI’s PRO Common Terminology Criteria for Adverse Events (0-4, higher = worse severity); EuroQoL-5 dimensions assessing health status (0-100, higher = better health) and problems with self-care, and the Sloan Global QOL scale (0-10, higher = better QOL). Statistical tests included Spearman’s correlation rho (r) and multivariable linear regression. Results: 977 baseline PRO measures were completed by 247 patients (median age = 59 y; 46% female). Worst symptom-related interference was with activity (3.0 on a 0-10 scale), work (2.9), and enjoyment of life (2.4). Composite score means were 2.8 for symptom interference with walking, activity, and work (WAW; activity-related functioning), and 2.1 for interference with relationships, enjoyment of life, and mood (REM; mood-related functioning). Symptoms most associated with worse WAW were fatigue (P&lt;0.001) and appetite loss (P=0.001). Worse WAW was linked to worse REM (r=0.78, P&lt;0.001). Diminished sexual interest/mood (DSI) was associated with worse WAW (r=0.35, P&lt;0.001) and REM (r=0.33, P&lt;0.001). Worse WAW was linked to shorter trial duration (P=0.003) and worse response (progression of disease/immune-related progression) on the clinical trial (P=0.05). Conclusions: This first, comprehensive and prospective examination of symptom interference with functioning at trial baseline found that worse symptom interference was linked to worse QOL, poorer clinical outcomes, and shorter trial duration. These findings suggest that baseline patient-reported symptom interference with functioning can serve as a potential biomarker of poor prognosis in investigational trials, and that trial patients may benefit from initiation of supportive care prior to trial start. [Table: see text]

Patient-reported outcomes in N1 breast cancer: A phase III trial comparing whole-breast to whole-breast plus regional irradiation after taxane-based chemotherapy (KROG 1701).

577 Background: Recent randomized trials have highlighted the benefits of regional node irradiation (RNI) in high-risk node-positive or pN1 breast cancer, yet its impact in the context of modern taxane-based adjuvant chemotherapy remains unclear. In this multi-center phase III trial, we study to prove the hypothesis that there is no difference in terms of disease-free survival between standard whole-breast irradiation (WBI) with RNI and WBI alone in pN1 breast cancer patients receiving taxane-based adjuvant chemotherapy. Comprehensive patient-reported outcomes (PROs) collected at multiple time points are now reported. Methods: The KROG 17-01 trial (NCT03269981), a prospective, multicenter, non-inferiority study, randomized patients with pN1 breast cancer after breast-conserving surgery and adjuvant taxane-containing chemotherapy to WBI or WBI+RNI. Both conventional and hypofractionated radiotherapy (RT) were allowed. PROs were assessed using the EORTC QLQ-C30 and QLQ-BR23 modules. All data were collected at baseline, during RT, and at follow-up intervals of 3-6 months, 1, 2, 3, 4, and 5 years post-treatment. Linear mixed models were used to compare PROs between treatment arms. Results: From April 2017 to December 2021, 840 patients were enrolled; 777 received intervention as assigned, and 750 completed baseline PRO questionnaires (387 in WBI+RNI, 363 in WBI). Overall, PRO domains improved over time (p&lt;0.001). During RT, the WBI+RNI group experienced more fatigue, nausea, and vomiting (p&lt;0.05), and reported lower global health (p=0.090) and physical functioning (p=0.049) with borderline significance compared to the WBI group. At 3-6 months post-RT, WBI+RNI group also showed higher arm symptom scores (p=0.030). Apart from these specific timepoints, no significant differences were observed in other PRO domain scores, including arm and breast symptoms, between treatment arms. In addition, there was no significant differences in PRO domains according to RT techniques and fractionation, except for breast symptoms during RT, favoring hypofractionation and intensity-modulated RT. Conclusions: In patients with pN1 breast cancer treated with taxane-based adjuvant chemotherapy, adding RNI was associated with minor, transient declines in specific PRO domains. However, these differences were not clinically significant, indicating comparable overall patient experiences between the two treatment arms. Clinical trial information: NCT03269981 .

Patient-reported outcomes (PROs) from a randomized, phase 3 trial of enfortumab vedotin plus pembrolizumab (EV+P) versus platinum-based chemotherapy (PBC) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

4502 Background: EV+P nearly doubled median progression-free survival and overall survival vs PBC in patients (pts) with previously untreated la/mUC in the phase 3 EV-302 trial. PROs are reported here. Methods: In EV-302 (NCT04223856) pts were randomized 1:1 to EV+P or PBC (gemcitabine with cisplatin or carboplatin). PRO assessments included the EORTC Quality of Life Questionnaire (EORTC QLQ-C30), and the Brief Pain Inventory Short Form (BPI-SF) completed at baseline, weekly for 12 weeks (wks), then every 3 wks through survival follow-up, inclusive of the time post-progression. Time to pain progression (TTPP) and mean change from baseline in worst pain at wk 26 using the BPI-SF were prespecified analyses statistically tested using a gatekeeping strategy. Mean change from baseline through wk 26 and time to confirmed deterioration (TTCD) of EORTC-QLQ-C30 and BPI-SF domains were prespecified descriptive analyses. TTPP and TTCD were assessed using Kaplan-Meier methods. Results: Of 886 pts randomized, 731 (376 received EV+P; 355 PBC) completed baseline PRO questionnaires. Compliance rates differed between arms and remained &gt;70% through wk 29 for EV+P and through only wk 17 for PBC. Median TTPP was 14.2 months (mos) with EV+P and 10.0 mos with PBC (hazard ratio [HR]=0.92; 95% CI=0.72, 1.17; 2-sided p-value=0.48). The least squares (LS) mean reduction in worst pain at wk 26 was numerically greater with EV+P vs PBC (-0.61 vs -0.03, LS mean difference [95% CI]: -0.58 [-1.05, -0.11] [nominal 2-sided p-value=0.015]). Pts with moderate to severe pain at baseline who were treated with EV+P (n=128, 34%) had a meaningful (&gt;2 pt) improvement from baseline in BPI worst pain from wk 3 through 26. In EORTC QLQ-C30 Global Health Status/Quality of Life [GHS/QoL], EV+P demonstrated a transient worsening at wk 3 (-6.3) that returned to baseline from wks 4 through 26, while patients treated with PBC demonstrated deterioration from wk 1 through wk 17 (range -1.2 to -7.1) when scores returned to baseline. TTCD for EORTC QLQ-C30 GHS/QoL was 5.9 mos with EV+P vs 3.2 mos with PBC (HR = 0.98 [95% CI]: 0.79 – 1.2). Conclusions: Pts treated with EV+P have improved survival compared with PBC without detriment to quality of life and functioning, further supporting the value of EV+P for pts with la/mUC. Compliance, especially after progression, was lower than expected (particularly in the PBC arm) and may have impacted the results. Clinical trial information: NCT04223856 .

Abstract PO1-11-10: Use of a standardized tool for the evaluation and treatment of cancer related cognitive impairment (chemo-brain) among breast cancer patients

Abstract There is a steep linear increase in patients surviving a cancer diagnosis. Clinical solutions that address the high prevalence of cancer-related treatment effects (CRTE) are urgently needed. A stark example of this need is the dearth of screening and treatment programs for cancer related cognitive impairment (CRCI) (colloquially called “chemo-brain”). Up to 75% of cancer patients report neurocognitive changes that leave patients unable to cope with the expectations of employers, colleagues, families, and friends. The prevalence of neurological disorders is 275% higher among adult cancer patients, when compared to an adult cancer-free population. For many adolescent and young adult cancer patients, the onset of CRCI occurs during "cognitive prime time"; a time when individuals are pursuing education, careers, and raising families. To address a gap in CRTE we have implemented a virtual multi-disciplinary intervention to measure and treat CRCI. Our CRCI intervention follows National Comprehensive Cancer Network and American Society of Clinical Oncology (ASCO) guidelines for CRCI. These guidelines indicate a multi-disciplinary approach with emphasis on increasing physical activity levels, cognitive-behavioral therapy, memory adaptive training, mood management, and sleep optimization. Our approach also follows recent ASCO guidelines for nutrition counseling. Our CRCI program utilizes medical oncologists, physician assistants, mental health therapists, registered dietitians, and occupational therapists. A nationally validated patient reported outcome (PRO) measurement, analysis, and reporting platform informs clinical treatment pathways, monitors patient progress, guides clinical decision making, and improves patient/provider communication. Using health status measures for CRCI, and following American Cancer Society and ASCO guidelines, patients are risk-stratified into three personalized cancer survivor care pathways: 1) low-complexity patients; 2) medium-complexity patients; and 3) high-complexity patients. Low-complexity patients baseline PROs score in the normal range, medium-complexity patients are those who score below the norm (moderate to large effect size difference from normal), and high-complexity patients are those who score well below the norm (greater than larger effect size difference from normal). Low-complexity patients are enrolled into a self-management and continuation of care program. Medium-complexity patients are enrolled into a shared care program. High-complexity patients are enrolled into an acute care program. All three clinical pathways include continued risk-factor vital-sign surveillance. Nearly 100% (99%) of patients who enroll in our primary cancer survivor care program complete our PRO baseline (N=80). From a convenient sample of breast cancer patients (N=42), provisional results of patient-specific segmentation analyses reveal a nearly perfect bell-shaped curve, with 51% of the population classified within the definition of medium-complexity and even split of outliers (high-complexity 24% and low-complexity 24%). Additionally, of all patients in our primary cancer survivor care program who completed at least three measurement time points for health status measures of cognitive impartment (N=38), 92% had a positive experience, 71% had a clinically significant improvement in cognitive health, 21% had a no change in cognitive status, and only 8% had a decline in cognitive health. If these data, and PRO implementation approach hold true, this program could be scaled to national and international cancer survivor population suffering from CRCI. Citation Format: John Librett, Mark Kosinski, Gregory Litton. Use of a standardized tool for the evaluation and treatment of cancer related cognitive impairment (chemo-brain) among breast cancer patients [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-11-10.

Abstract PO1-11-06: Evaluating Symptom Clusters in Patients with Breast Cancer Experiencing Aromatase Inhibitor-Associated Musculoskeletal Symptoms

Abstract Background: Although treatment with an aromatase inhibitor (AI) for 5-10 years decreases 10-year breast cancer mortality by about 40%, up to 25% of patients will stop treatment early because of treatment-related, intolerable joint and muscular pain and stiffness, called aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). We previously identified that nociplastic pain, or chronic pain in the absence of tissue damage or inflammation, is associated with increased likelihood of developing AIMSS. Other studies have found that symptom clusters, such as the SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy/fatigue) are prevalent and co-occur in patients with cancer. Here we examine the prevalence of SPPADE symptoms for patients experiencing AIMSS and willing to enroll on a clinical trial examining use of cannabidiol (CBD) to treat their symptoms. Methods: Patients with stage 0-3 hormone receptor-positive breast cancer experiencing AIMSS (defined as worst joint pain ≥4/10 during prior 7 days that developed or worsened since starting AI therapy) were eligible for enrollment in this single arm, single center phase 2 open label clinical trial (NCT04754399). Enrolled patients completed validated questionnaires at baseline and then received CBD (Epidiolex) for 15 weeks. Patient-reported outcomes (PRO) data was collected serially, including the following questionnaires which addressed SPPADE symptoms: Brief Pain Inventory (BPI) to assess pain, PROMIS Profile 29+2 v2.1 to assess multiple symptoms, and Fibromyalgia Survey (FMS) to assess nociplastic pain. Results: 39 patients enrolled on this clinical trial. The median age at enrollment was 57 (range 37-59) and 21% of patients were over age 70. The majority of patients were white (92%) and average BMI was 31 (SD 6.6). Anastrozole was the most used aromatase inhibitor (74%), followed by exemestane (18%), and letrozole (8%). 5 patients (13%) required concomitant GnRHa therapy. Baseline PRO data was obtained from 37 patients. BPI average pain score over the week prior to enrollment was 5.1 (SD 1.5) and worst pain score was 7.2 (SD 1.3). Pain interference reported on the BPI was 4.1 (SD 2.1). Compared to the general population, enrolled patients reported better physical function (T-score 60.2, SE 3.7), less depression (T-score 45.5, SE 4.7) and fatigue (T-score 46.7, SE 5.1), and similar levels of anxiety (T-score 51, SE 7.1) and sleep disturbance (T-score 49.5, SE 5.9) on the PROMIS Profile. On the FMS, 62% of patients had evidence of nociplastic pain, with average score 13.3 (SD 5.7). The median number of sites of pain in the body reported by patients was 8 (range 1-16). Conclusions: While patients enrolling on an AIMSS clinical trial reported a high degree of daily pain that regularly interferes with their activities, for most patients these symptoms did not appear to have a negative impact on mood, affect, or other symptoms that typically cluster with pain. Though it is difficult to extrapolate results from a small population, the unexpected absence of co-occurring symptoms in this population raises additional questions about the interplay of AIMSS and other symptoms commonly reported in interventional AIMSS studies. Follow-up PRO data will be obtained in this clinical trial, allowing us to examine the impact of CBD use on pain, pain interference, and other patient-reported symptoms, as well as to explore which patients are more likely to obtain benefit from CBD treatment. Funding support provided by Conquer Cancer, the ASCO Foundation and the Rising Tide Foundation for Clinical Cancer Research. Citation Format: Fleege Nicole, N. Lynn Henry. Evaluating Symptom Clusters in Patients with Breast Cancer Experiencing Aromatase Inhibitor-Associated Musculoskeletal Symptoms [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-11-06.

Quantifying Patient Expectations for Total Knee Arthroplasty: Expectations for Improvement Are Greater Than Minimal Clinically Important Difference

BackgroundAchieving a minimal clinically important difference (MCID) in patient-reported outcomes following total knee arthroplasty (TKA) is common, yet up to 20% patient dissatisfaction persists. Unmet expectations may explain post-TKA dissatisfaction. No prior studies have quantified patient expectations using the same patient-reported outcome metric as used for MCID to allow direct comparison. MethodsThis was a prospective study of patients undergoing TKA with 5 fellowship-trained arthroplasty surgeons at one academic center. Baseline Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) domains were assessed. Expected PROMIS scores were determined by asking patients to indicate the outcomes they were expecting at 12 months postoperatively. Predicted scores were generated from a predictive model validated in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR) dataset. T-tests were used to compare baseline, expected, and predicted PROMIS scores. Expected scores were compared to PROMIS MCID values obtained from the literature. Regression models were used to identify patient characteristics associated with high expectations. ResultsThere were 93 patients included. Mean age was 67 years (range, 30 to 85) and 55% were women. Mean baseline PROMIS PF and PI was 34.4 ± 6.7 and 62.2 ± 6.4, respectively. Patients expected significant improvement for PF of 1.9 times the MCID (MCID = 11.3; mean expected improvement = 21.6, 95% confidence interval [CI] 19.6 to 23.5, P < .001) and for PI of 2.3 times the MCID (MCID = 8.9; mean expected improvement = 20.6, 95% CI 19.1-22.2, P < .001). Predicted scores were significantly lower than expected scores (mean difference = 9.5, 95% CI 7.7 to 11.3, P < .001). No unique patient characteristics were associated with high expectations (P > .05). ConclusionsTo our knowledge, this study is the first to quantify preoperative patient expectations using the same metric as MCID to allow for direct comparison. Patient expectations for improvement following TKA are ∼2× greater than MCID and are significantly greater than predicted outcome scores. This discrepancy challenges currently accepted standards of success after TKA and indicates a need for improved expectation setting prior to surgery.

Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer (TOPAZ-1): patient-reported outcomes from a randomised, double-blind, placebo-controlled, phase 3 trial

In the ongoing, randomised, double-blind phase 3 TOPAZ-1 study, durvalumab, a PD-L1 inhibitor, plus gemcitabine and cisplatin was associated with significant improvements in overall survival compared with placebo, gemcitabine, and cisplatin in people with advanced biliary tract cancer at the pre-planned intermin analysis. In this paper, we present patient-reported outcomes from TOPAZ-1. In TOPAZ-1 (NCT03875235), participants aged 18 years or older with previously untreated, unresectable, locally advanced, or metastatic biliary tract cancer with an Eastern Cooperative Oncology Group performance status of 0 or 1 and one or more measurable lesions per Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) were randomly assigned (1:1) to the durvalumab group or the placebo group using a computer-generated randomisation scheme. Participants received 1500 mg durvalumab or matched placebo intravenously every 3 weeks (on day 1 of the cycle) for up to eight cycles in combination with 1000 mg/m2 gemcitabine and 25 mg/m2 cisplatin intravenously on days 1 and 8 every 3 weeks for up to eight cycles. Thereafter, participants received either durvalumab (1500 mg) or placebo monotherapy intravenously every 4 weeks until disease progression or other discontinuation criteria were met. Randomisation was stratified by disease status (initially unresectable vs recurrent) and primary tumour location (intrahepatic cholangiocarcinoma vs extrahepatic cholangiocarcinoma vs gallbladder cancer). Patient-reported outcomes were assessed as a secondary outcome in all participants who completed the European Organisation for Research and Treatment of Cancer's 30-item Quality of Life of Cancer Patients questionnaire (QLQ-C30) and the 21-item Cholangiocarcinoma and Gallbladder Cancer Quality of Life Module (QLQ-BIL21). We calculated time to deterioration-ie, time from randomisation to an absolute decrease of at least 10 points in a patient-reported outcome that was confirmed at a subsequent visit or the date of death (by any cause) in the absence of deterioration-and adjusted mean change from baseline in patient-reported outcomes. Between April 16, 2019, and Dec 11, 2020, 685 participants were enrolled and randomly assigned, 341 to the durvalumab group and 344 to the placebo group. Overall, 345 (50%) of participants were male and 340 (50%) were female. Data for the QLQ-C30 were available for 318 participants in the durvalumab group and 328 in the placebo group (median follow-up 9·9 months [IQR 6·7 to 14·1]). Data for the QLQ-BIL21 were available for 305 participants in the durvalumab group and 322 in the placebo group (median follow-up 10·2 months [IQR 6·7 to 14·3]). The proportions of participants in both groups who completed questionnaires were high and baseline scores were mostly similar across treatment groups. For global health status or quality of life, functioning, and symptoms, we noted no difference in time to deterioration or adjusted mean changes from baseline were observed between groups. Median time to deterioration of global health status or quality of life was 7·4 months (95% CI 5·6 to 8·9) in the durvalumab group and 6·7 months (5·6 to 7·9) in the placebo group (hazard ratio 0·87 [95% CI 0·69 to 1·12]). The adjusted mean change from baseline was 1·23 (95% CI -0·71 to 3·16) in the durvalumab group and 0·35 (-1·63 to 2·32) in the placebo group. The addition of durvalumab to gemcitabine and cisplatin did not have a detrimental effect on patient-reported outcomes. These results suggest that durvalumab, gemcitabine, and cisplatin is a tolerable treatment regimen in patients with advanced biliary tract cancer. AstraZeneca.

Hip Osteoarthritis in Patients Undergoing Surgery for Severe Adult Spinal Deformity: Prevalence and Impact on Spine Surgery Outcomes.

Hip osteoarthritis (OA) is common in patients with adult spinal deformity (ASD). Limited data exist on the prevalence of hip OA in patients with ASD, or on its impact on baseline and postoperative alignment and patient-reported outcome measures (PROMs). Therefore, this paper will assess the prevalence and impact of hip OA on alignment and PROMs. Patients with ASD who underwent L1-pelvis or longer fusions were included. Two independent reviewers graded hip OA with the Kellgren-Lawrence (KL) classification and stratified it by severity into non-severe (KL grade 1 or 2) and severe (KL grade 3 or 4). Radiographic parameters and PROMs were compared among 3 patient groups: Hip-Spine (hip KL grade 3 or 4 bilaterally), Unilateral (UL)-Hip (hip KL grade 3 or 4 unilaterally), or Spine (hip KL grade 1 or 2 bilaterally). Of 520 patients with ASD who met inclusion criteria for an OA prevalence analysis, 34% (177 of 520) had severe bilateral hip OA and unilateral or bilateral hip arthroplasty had been performed in 8.7% (45 of 520). A subset of 165 patients had all data components and were examined: 68 Hip-Spine, 32 UL-Hip, and 65 Spine. Hip-Spine patients were older (67.9 ± 9.5 years, versus 59.6 ± 10.1 years for Spine and 65.8 ± 7.5 years for UL-Hip; p < 0.001) and had a higher frailty index (4.3 ± 2.6, versus 2.7 ± 2.0 for UL-Hip and 2.9 ± 2.0 for Spine; p < 0.001). At 1 year, the groups had similar lumbar lordosis, yet the Hip-Spine patients had a worse sagittal vertebral axis (SVA) measurement (45.9 ± 45.5 mm, versus 25.1 ± 37.1 mm for UL-Hip and 19.0 ± 39.3 mm for Spine; p = 0.001). Hip-Spine patients also had worse Veterans RAND-12 Physical Component Summary scores at baseline (25.7 ± 9.3, versus 28.7 ± 9.8 for UL-Hip and 31.3 ± 10.5 for Spine; p = 0.005) and 1 year postoperatively (34.5 ± 11.4, versus 40.3 ± 10.4 for UL-Hip and 40.1 ± 10.9 for Spine; p = 0.006). This study of operatively treated ASD revealed that 1 in 3 patients had severe hip OA bilaterally. Such patients with severe bilateral hip OA had worse baseline SVA and PROMs that persisted 1 year following ASD surgery, despite correction of lordosis. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Predictors of quality of life, functional status, depression and fatigue in early arthritis: comparison between clinically suspect arthralgia, unclassified arthritis and rheumatoid arthritis

BackgroundRheumatoid arthritis (RA) is often preceded by symptomatic phases during which classification criteria are not fulfilled. The health burden of these “at-risk” stages is not well described. This study assessed health-related quality of life (HRQoL), function, fatigue and depression in newly presenting patients with clinically suspect arthralgia (CSA), unclassified arthritis (UA) or RA.MethodsCross-sectional analysis of baseline Patient-Reported Outcome Measures (PROMs) was conducted in patients from the Birmingham Early Arthritis Cohort. HRQoL, function, depression and fatigue at presentation were assessed using EQ-5D, HAQ-DI, PHQ-9 and FACIT-F. PROMs were compared across CSA, UA and RA and with population averages from the HSE with descriptive statistics. Multivariate linear regression assessed associations between PROMs and clinical and sociodemographic variables.ResultsOf 838 patients included in the analysis, 484 had RA, 200 had CSA and 154 had UA. Patients with RA reported worse outcomes for all PROMs than those with CSA or UA. However, “mean EQ-5D utilities were 0.65 (95%CI: 0.61 to 0.69) in CSA, 0.61 (0.56 to 0.66) in UA and 0.47 (0.44 to 0.50) in RA, which was lower than in general and older (≥ 65 years) background populations.” In patients with CSA or UA, HRQoL was comparable to chronic conditions such as heart failure, severe COPD or mild angina. Higher BMI and older age (≥ 60 years) predicted worse depression (PHQ-9: -2.47 (-3.85 to -1.09), P < 0.001) and fatigue (FACIT-F: 5.05 (2.37 to 7.73), P < 0.001). Women were more likely to report worse function (HAQ-DI: 0.13 (0.03 to 0.21), P = 0.01) and fatigue (FACIT-F: -3.64 (-5.59 to -1.70), P < 0.001), and residents of more deprived areas experienced decreased function (HAQ-DI: 0.23 (0.10 to 0.36), P = 0.001), greater depression (PHQ-9: 1.89 (0.59 to 3.18), P = 0.004) and fatigue (FACIT-F: -2.60 (-5.11 to 0.09), P = 0.04). After adjustments for confounding factors, diagnostic category was not associated with PROMs, but disease activity and polypharmacy were associated with poorer performance across all PROMs.ConclusionsPatient-reported outcomes were associated with disease activity and sociodemographic characteristics. Patients presenting with RA reported a higher health burden than those with CSA or UA, however HRQoL in the pre-RA groups was significantly lower than population averages.

Relating preoperative MCS-12 to microdiscectomy outcomes

PurposeTo determine the impact of poor mental health on patient-reported and surgical outcomes after microdiscectomy.MethodsPatients ≥ 18 years who underwent a single-level lumbar microdiscectomy from 2014 to 2021 at a single academic institution were retrospectively identified. Patient-reported outcomes (PROMs) were collected at preoperative, three-month, and one-year postoperative time points. PROMs included the Oswestry Disability Index (ODI), Visual Analog Scale Back and Leg (VAS Back and VAS Leg, respectively), and the mental and physical component of the short form-12 survey (MCS and PCS). The minimum clinically important differences (MCID) were employed to compare scores for each PROM. Patients were categorized as having worse mental health or better mental health based on a MCS threshold of 50.ResultsOf 210 patients identified, 128 (61%) patients had a preoperative MCS score ≤ 50. There was no difference in 90-day surgical readmissions or spine reoperations within one year. At 3- and 12-month time points, both groups demonstrated improvements in all PROMs (p < 0.05). At three months postoperatively, patients with worse mental health had significantly lower PCS (42.1 vs. 46.4, p = 0.004) and higher ODI (20.5 vs. 13.3, p = 0.006) scores. Lower mental health scores were associated with lower 12-month PCS scores (43.3 vs. 48.8, p < 0.001), but greater improvements in 12-month ODI (− 28.36 vs. − 18.55, p = 0.040).ConclusionWhile worse preoperative mental health was associated with lower baseline and postoperative PROMs, patients in both groups experienced similar improvements in PROMs. Rates of surgical readmissions and reoperations were similar among patients with varying preoperative mental health status.

Preoperative Function Affects Ability to Achieve One-Year Minimum Clinically Important Difference for Patients Undergoing Total Knee Arthroplasty

BackgroundMinimum clinically important difference (MCID) values are commonly used to measure treatment success for total knee arthroplasty (TKA). MCID values vary according to calculation methodology, and prior studies have shown that patient factors are associated with failure to achieve MCID thresholds. The purpose of this study was to determine if anchor-based 1-year Knee Injury and Osteoarthritis Outcome Score Joint Replacement (KOOS-JR) MCID values varied among patients undergoing TKA based on patient-specific factors. MethodsThis was a retrospective review of patients undergoing TKA from 2017-2018. Patients without baseline or 1-year KOOS-JR or Patient-Reported Outcome Measurement Information System Global Health data or that underwent procedures other than primary TKA were excluded. MCIDs were calculated and compared between patient groups according to preoperative characteristics. ResultsAmong the included 976 patients, 1-year KOOS-JR MCIDs were 26.6 for men, 28.2 for women, 30.7 for patients with a diagnosis of anxiety and/or depression, and 26.7 for patients without a diagnosis. One-year MCID values did not differ significantly according to gender (P = .379) or mental health diagnosis (P = .066), nor did they correlate with body mass index (β = −0.034, P = .822). Preoperative KOOS-JR decile demonstrated an inverse relationship with 1-year MCID values and attainment of MCID. ConclusionsThe proportion of patients attaining KOOS-JR MCID values demonstrated an inverse relationship with preoperative baseline function. Future investigation may identify patient factors that allow surgeons to better capture patient satisfaction with their procedure despite failure to attain a 1-year MCID.