Improvements In Patient-reported Outcomes Research Articles

Failed labral reconstruction of the hip can be successfully revised to another labral reconstruction: improved patient-reported outcomes at a minimum of 2-year follow-up

Abstract The purpose of this study was to validate the success of revision arthroscopic circumferential allograft labral reconstruction (CLR) in nonarthritic hips, which, in the rare case of failure, had previously undergone labral reconstruction by the same surgeon. Using a minimum of 24-month follow-up, data from 24 hips having undergone revision CLR were analyzed to determine improvements in patient-reported outcomes (PROs). All included cases completed a minimum of 24 months follow-up, with a success rate of 96%. All PROs improved significantly, with exceptionally strong measures of effect. Modified Harris Hip Scores improved by a mean of 26.68 points, with 88% of patients meeting the minimal clinically important difference (MCID) (+6.49, P ≤ .001, d = 1.32). Lower Extremity Functional Scale scores improved by a mean of 21.88 points, with 78% of patients meeting the MCID (+7.79, P ≤ .001, d = 1.32). Pain as rated by the Visual Analog Scale, including at rest, during activities of daily living, and with sports, was significantly improved with strong measures of effect, with >75% of patients having met the MCID. This study validated that a failed labral reconstruction of the hip can be revised safely and effectively to another labral reconstruction of the hip. While labral reconstruction has broadly been shown to result in highly favorable outcomes, this study demonstrated that in the rare case of failure, revision CLR is not only feasible but results in improved pain and functionality.

Lifestyle intervention improves cognition and quality of life in persons with early Multiple Sclerosis

BackgroundLifestyle changes have been demonstrated to impact pathophysiology in Multiple Sclerosis (MS). Various diet and exercise protocols have been reported to improve symptoms and function in persons with MS. Evidence is accumulating that interventions as early as possible in the disease course are warranted. The objective of this study was to investigate the effect of a remotely delivered lifestyle program focusing on specific diet and exercise recommendations in persons with early MS. MethodsMS patients, with disease diagnosis no more than 2 years prior, were recruited from the patient population of the MS clinic of the Pacific Neuroscience Institute. Participants followed recommendations for diet and exercise delivered via remote heath coaching. Each participant received 6 sessions with a health coach over a 12-week period. They were given parameters of a Mediterranean-type diet to follow, and specific and individualized recommendations about duration, intensity and type of exercise and physical activity. Outcome measures included Quality of Life (QOL), cognition (Symbol Digit Modalities Test, SDMT), fatigue (Multiple Sclerosis Fatigue Impact Scale, MFIS), fitness (estimated with Metabolic equivalents, METS) and other objective and patient reported outcomes (PRO). Changes in outcomes were analyzed using mixed effects general linear models and standardized pre-post differences.(Cohen's d) ResultsFifteen persons with early (≤ 2 years) MS enrolled in the study, 14 of whom completed the study. We observed significant improvements in QOL (p = 0.02), SDMT (p = 0.006), fatigue(p = 0.005), fitness (p = 0.04), and other PRO and objective metrics at the end of the protocol compared to baseline. Adherence and patient satisfaction measures were high. ConclusionsSpecific and individualized lifestyle recommendations can be effectively delivered remotely, and may produce improvement in symptoms and function in persons with early MS. Larger controlled trials of these interventions are warranted.

The influence of preoperative 12-item veterans rand physical component scores on outcomes following cervical disc replacement.

To evaluate the influence of preoperative VR-12 physical component scores (PCS) on outcomes following cervical disc replacement (CDR). Patients undergoing elective CDR were retrospectively identified. Patient-reported outcomes (PROs) of interest included VR-12 PCS/VR-12 Mental Component Score (MCS)/9-Item Patient Health Questionnaire (PHQ-9)/Short Form-12 (SF-12) PCS and MCS/Patient-Reported Outcome Measurement Information System-Physical Function (PROMIS-PF)/Visual Analog Scale-Neck Pain (VAS-NP)/VAS-Arm Pain (VAS-AP)/Neck Disability Index (NDI). Baseline up to two-year postoperative scores were obtained (average follow-up: 9.2 ± 6.8months). Two cohorts were created: VR-12 PCS < 35 or VR-12 PCS ≥ 35. Improvements in scores from baseline to six weeks postoperatively and to final follow-up were calculated. Changes in scores were compared to previously reported thresholds to determine rates of minimum clinically important difference (MCID). Of 127 patients, 64 were in the worse VR-12 PCS group. Patients with better VR-12 PCS were more likely to have private insurance (p = 0.034). When accounting for insurance differences, the worse VR-12 PCS group reported inferior NDI/VAS-NP/PHQ-9/PROMIS-PF/VR-12 PCS/SF-12 PCS at six weeks and final follow-up (p ≤ 0.015, all). The worse VR-12 PCS group reported greater improvements in VAS-AP and VR-12 PCS by six weeks and in NDI/VR-12 MCS/VR-12 PCS/SF-12 PCS by final follow-up (p ≤ 0.026, all). Patients with worse VR-12 PCS reported greater MCID achievement for VR-12 MCS and SF-12 PCS (p ≤ 0.034, both). Following surgery, patients with worse VR-12 PCS report greater improvements in PROs, highlighting the increased relative impact of surgery for patients with worse baseline physical function. These findings can be used to optimize patient experience perioperatively and inform postoperative expectations.

Association of Neighborhood Level Socioeconomic Status and Patient Reported Clinical Improvement Following Total Shoulder Arthroplasty

BackgroundPrior studies have demonstrated higher preoperative pain and decreased patient reported outcomes (PROs) following total shoulder arthroplasty (TSA) in individuals with lower socioeconomic status (SES). The goal of this study was to investigate the rate of clinical improvement following TSA in individuals with differing SES. MethodsIndividuals included in this study underwent anatomic (a)TSA or reverse (r)TSA by two surgeons between May 2018 and January 2021. Patients were split into three SES groups (low, moderate, and high) based on neighborhood SES level as determined by Area Deprivation Index (ADI). PROs were collected preoperatively and at 9 weeks, 26 weeks, 1 year, and 2 years postoperatively. Shoulder specific PROs included the American Shoulder and Elbows Surgeon’s shoulder score (ASES), 10-point visual analog scale (VAS) for pain, single assessment numeric evaluation (SANE), and Western Ontario Osteoarthritis of the Shoulder Index (WOOS). The Veterans Rand 12 item health survey (VR-12) was utilized to measure overall well-being. We utilized a mixed design analysis of variance (ANOVA) to determine the interaction of time and improvement in PROs following surgery followed by one-way ANOVA with post-hoc analysis. Results/Discussion170 individuals (low SES n=34, moderate n=90, high n=46) met inclusion criteria and were included in this study. There were no significant differences between groups for BMI or age at time of surgery. All groups significantly improved from baseline scores on all PROs (p<.001) with the majority of improvement being achieved within the first year after surgery. There were no significant differences in rate of clinical improvement on PROs among the groups when compared to their respective preoperative scores. Significant differences were discovered when comparing groups independent of time with the low and moderate SES groups scoring significantly lower on ASES when compared to the high SES group (p<.01) and the low SES group reporting significantly higher VAS pain when compared to the high SES group (p=.034). ConclusionIndividuals with lower SES at the neighborhood level report higher pain and decreased shoulder function both preoperatively and postoperatively following TSA; however, the rate of clinical improvement following surgery in this group is comparable to individuals with higher SES when compared to baseline scores. All groups demonstrated significant improvement following surgery, suggesting TSA remains a successful operation regardless of SES.

Item Response Theory Quantifies the Relationship Between Improvements in Serum Phosphate and Patient-Reported Outcomes in Adults With X-Linked Hypophosphatemia.

Burosumab is indicated for treatment of a rare bone disease, X-linked hypophosphatemia (XLH). The aim of this analysis was to evaluate the relationship between a treatment response biomarker and patient-reported outcomes (PROs). Longitudinal data for PROs were obtained from adults with XLH from a phase III study. Individual rich time profiles of the biomarker, serum phosphate were simulated using a prior population pharmacokinetic-pharmacodynamic model to calculate serum phosphate exposure metrics for each 28-day treatment cycle, which were then merged with PROs data. Item response theory parameters were first estimated to map a latent variable, ψ, that is, disability score, relative to baseline. Next, the relationships between serum phosphate exposures and ψ were modeled using a nonlinear mixed-effect (NLME) modeling approach. A combined item response theory-NLME model with average serum phosphate as a predictor of ψ described PROs data well. The model estimates suggested 28%, 31%, and 25% reduction in Western Ontario and McMaster Universities Osteoarthritis Index, brief pain inventory, and brief fatigue inventory scores, respectively, with every unit increase in average serum phosphate from the lower limit of normal (2.5 mg/dL). Additionally, a time effect of ~ 0.08% improvements each week was estimated. The analysis suggested that burosumab treatment-induced improvements in serum phosphate levels are associated with improvements in PROs in adults with X-linked hypophosphatemia. The analyses confirmed the importance of prolonged serum phosphate level correction in adult patients with XLH. These results can be useful to guide the design of further studies and to design treatment optimization strategies.

Patients With Dysplasia Achieve Similar Outcomes and Survivorship to Nondysplastic Patients 10 Years After Hip Arthroscopy for Femoroacetabular Impingement

To determine the long-term outcomes of hip arthroscopy (HA) for femoroacetabular impingement (FAI) in the presence of concomitant lateral rim dysplasia compared with a matched control group. Patients undergoing HA between January 2009 and October 2013 with minimum 10-year follow-up were reviewed. The inclusion criteria consisted of patients undergoing HA for FAI with evidence of lateral rim dysplasia (lateral-center edge angle [LCEA] < 25°). Patients with lateral rim dysplasia were matched to patients with an LCEA greater than 30° based on sex, Tönnis grade, and age. Outcomes included survival (avoidance of total hip replacement [THR]), repeated HA, and patient-reported outcomes (PROs). Survivorship was assessed using a Kaplan-Meier curve and log rank test, whereas revision rates between groups were assessed using χ2 analysis. Between- and within-group analyses of PROs were conducted using the Mann-Whitney U test and Wilcoxon signed rank test, respectively. The proportion of cases achieving the patient acceptable symptom state was compared between groups using χ2 analysis. This study comprised 46 dysplasia cases and 90 control cases. There was no statistically significant difference between groups in baseline metrics apart from the LCEA (P < .001), Sharp angle (P < .001), and Tönnis angle (P < .001). By 10 years postoperatively, 9% of dysplasia cases and 4% of control cases underwent conversion to THR. There was no statistically significant difference between groups in survival or revision rates. Both groups reported improvements in PROs, and there was no difference between PRO scores at either time point. Excluding cases that underwent THR, 84% and 83% of dysplasia and control cases, respectively, achieved the patient acceptable symptom state. HA for symptomatic FAI is a successful treatment in cases in which dysplasia is present. Low complication rates, comparable outcomes to cases without lateral rim dysplasia, and a high survivorship rate of 91% at minimum 10-year follow-up are observed. Increasing Tönnis angle preoperatively may increase the risk of THR conversion. Level IV, retrospective cohort study.

Durable control of psoriatic arthritis with guselkumab across domains and patient characteristics: post hoc analysis of a phase 3 study.

Evaluate patterns of stringent disease control with 2 years of guselkumab across key disease-identified domains and patient-reported outcomes (PROs) in subgroups of patients with psoriatic arthritis (PsA) defined by baseline characteristics. This post hoc analysis of DISCOVER-2 (Clinicaltrials.gov NCT03158285) evaluated biologic-naïve PsA patients (≥ 5 swollen/ ≥ 5 tender joints, C-reactive protein [CRP] ≥ 0.6 mg/dL) randomized to guselkumab every4weeks (Q4W); guselkumab at Weeks0and 4, thenQ8W; or placebo with crossover to guselkumab Q4W at Week24. Achievement of American College of Rheumatology 50/70% improvement (ACR50/70), Investigator's Global Assessment (IGA) 0, dactylitis/enthesitis resolution, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue response (≥ 4-point improvement), HAQ-Disability Index (HAQ-DI) response (≥ 0.35-point improvement), PsA Disease Activity Score (PASDAS) low disease activity (LDA), and minimal disease activity (MDA) was assessed at Weeks 24, 52, and 100 in subgroups defined by sex and baseline medication use, body mass index, PsA duration, swollen/tender joints, CRP, and psoriasis severity/extent. Patients with missing categorical response data were considered nonresponders. 442/493 (90%) guselkumab-randomized patients completed treatment through Week 100. Significant multi-domain efficacy of guselkumab versus placebo was shown across adequately sized patient subgroups. A pattern of continuous improvement was observed across key PsA domains and PROs within patient subgroups: 65%-85% of guselkumab-randomized patients had enthesitis/dactylitis resolution, 50%-70% achieved complete skin clearance, 60%-80% reported meaningful improvements in function/fatigue, 40%-65% achieved PASDAS LDA, and 35%-50% achieved MDA at Week100. Patients with active PsA receiving guselkumab demonstrated durable achievement of stringent endpoints associated with disease control across key PsA domains and PROs, regardless of baseline characteristics. Key Points • Among biologic-naïve patients with highly active psoriatic arthritis (PsA), efficacy of guselkumab across stringent disease endpoints and patient-reported outcomes (PROs) at Week 24 was consistent regardless of baseline demographics and disease characteristics. • Within guselkumab-randomized PsA patient subgroups, major improvements in joint disease activity, complete skin clearance, dactylitis/enthesitis resolution, clinically meaningful improvements in PROs, and achievement of low overall disease activity were maintained through Week 100. • Durable stringent endpoint achievement indicating disease control was observed with guselkumab, regardless of baseline patient or disease characteristics.

Peak nasal inspiratory flow assessment of polyp size and response from SYNAPSE

BackgroundIn the Phase III SYNAPSE study, mepolizumab plus standard of care (SoC) reduced nasal polyp score (NPS) versus placebo in patients with chronic rhinosinusitis with nasal polyps. ObjectiveInvestigate relationships between NPS and (1) peak nasal inspiratory flow (PNIF) and (2) patient-reported outcomes (PROs). MethodsIn this post hoc analysis, patients randomized 1:1 received mepolizumab 100 mg or placebo subcutaneously every 4 weeks (plus SoC). Changes from baseline in PNIF (Week 52), visual analog scale (VAS) scores (overall symptoms, nasal obstruction, loss of smell; Weeks 49–52), and 22-item Sino-Nasal Outcome Test (SNOT-22) total score (Week 52) were assessed in patients with NPS improvements (≥1-point) or without (<1-point, or worsening). ResultsPatients with NPS improvements had greater improvements in median (interquartile range [IQR]) PNIF (mepolizumab 50 L/min [10.5, 87.5], placebo 40 L/min [0, 85.0]) than those without (0.0 L/min [─10.0, 45.0], 0.0 L/min [─30.0, 30.0]); similar results were seen for median (IQR) change from baseline in overall symptoms (with: ─5.8 [─8.1, ─3.8], ─4.1 [─7.0, ─1.2]; without: ─1.3 [─6.3, 0.0], ─0.1 [─3.4, 0.0]), nasal obstruction (with: ─5.7 [─8.2, ─3.5], ─4.5 [─7.3, ─1.2]; without: ─1.3 [─6.6, 0.0], 0.0 [─3.6, 0.0]), loss of smell (with: ─2.8 [─7.9, 0.0], ─0.7 [─4.0, 0.0]; without: 0.0 [─2.4, 0.0], 0.0 [─0.3, 0.0]) VAS, and SNOT-22 total score (with: ─37.0 [─52.0, ─24.0], ─29.0 [─43.0, ─9.0]; without: ─16.0 [─42.0, 0.0], 0.0 [─27.0, 0.0]). ConclusionNPS improvement was associated with PNIF and PRO improvements irrespective of treatment. PNIF could be a useful non-invasive tool for monitoring nasal polyp size.

Efficacy of Atogepant in Chronic Migraine With and Without Acute Medication Overuse in the Randomized, Double-Blind, Phase 3 PROGRESS Trial.

Atogepant is an oral, calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine. We evaluated the efficacy of atogepant for the preventive treatment of chronic migraine (CM) in participants with and without acute medication overuse. This subgroup analysis of the phase 3, 12-week, randomized, double-blind, placebo-controlled PROGRESS trial evaluated adults with a ≥1-year history of CM, ≥15 monthly headache days (MHDs), and ≥8 monthly migraine days (MMDs) during the 4-week baseline period. Participants were randomized (1:1:1) to placebo, atogepant 30 mg twice daily (BID), or atogepant 60 mg once daily (QD) for 12 weeks and were analyzed by acute medication overuse status (triptans/ergots for ≥10 days per month, simple analgesics for ≥15 days per month, or combinations of triptans/ergots/simple analgesics for ≥10 days per month). Outcomes included change from baseline in mean MMDs, MHDs, and monthly acute medication use days; ≥50% reduction in mean MMDs across 12 weeks; and patient-reported outcome (PRO) measures. Of 755 participants in the modified intent-to-treat population, 500 (66.2%) met baseline acute medication overuse criteria (placebo, n = 169 [68.7%]; atogepant 30 mg BID, n = 161 [63.6%]; atogepant 60 mg QD, n = 170 [66.4%]). The least squares mean difference (LSMD) (95% CI) from placebo in MMDs was -2.7 (-4.0 to -1.4) with atogepant 30 mg BID and -1.9 (-3.2 to -0.6) with atogepant 60 mg QD. Mean MHDs (LSMD [95% CI] -2.8 [-4.0 to -1.5] and -2.1 [-3.3 to -0.8]) and mean acute medication use days (LSMD [95% CI] -2.8 [-4.1 to -1.6] and -2.6 [-3.9 to -1.3]) were reduced and a higher proportion of participants achieved ≥50% reduction in MMDs (odds ratio [95% CI] 2.5 [1.5-4.0] and 2.3 [1.4-3.7]) with atogepant 30 mg BID and atogepant 60 mg QD. There was a 52.1%-61.9% reduction in the proportion of atogepant-treated participants meeting acute medication overuse criteria over 12 weeks. Atogepant improved PRO measures. Similar results were observed in the subgroup without acute medication overuse. Atogepant was effective in participants with CM, with and without acute medication overuse, as evidenced by reductions in mean MMDs, MHDs, and acute medication use days; reductions in the proportion of participants meeting acute medication overuse criteria; and improvements in PROs. ClinicalTrials.gov NCT03855137. Submitted: February 25, 2019; first patient enrolled: March 11, 2019. clinicaltrials.gov/ct2/show/NCT03855137. This study provides Class II evidence that atogepant reduces mean MMDs, MHDs, and monthly acute medication use days in adult patients with or without medication overuse.

Sustained improvements in patient-reported outcomes after long-term sutimlimab in patients with cold agglutinin disease: results from the CADENZA study open-label extension

Cold agglutinin disease (CAD) is a rare subtype of autoimmune haemolytic anaemia characterised by classical complement pathway-mediated haemolysis, fatigue, and poor quality of life (QoL). Sutimlimab, a C1s inhibitor, rapidly halted haemolysis, and improved patient-reported outcomes (PROs) in patients with CAD in two phase 3 trials (CARDINAL and CADENZA). Here we report PROs from the CADENZA open-label extension (Part B). The first patient was enrolled in CADENZA (NCT03347422) in March 2018 (Part A) and the last patient completed the study in December 2021 (Part B). All patients who completed the 26-week Part A were eligible to receive biweekly doses of sutimlimab in Part B for up to 1 year after the last patient completed Part A. PROs were assessed throughout Part B, until the last on-treatment visit with available assessment (LV), and after a 9-week washout. In total, 32/39 patients completed Part B; median Part B treatment duration: 99 weeks. Patients switching from placebo to sutimlimab in Part B experienced rapid improvement in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score and other PROs. Sustained, clinically important improvements in FACIT-Fatigue were observed throughout Part B in patients who switched to sutimlimab and those continuing sutimlimab treatment (combined-group mean [SE] change from baseline at LV: 8.8 [2.1]). Similarly, the combined-group mean [SE] change for 12-Item Short Form Health Survey physical (4.9 [1.7]) and mental (4.0 [1.8]) component scores exceeded clinically important changes from baseline at LV. EuroQol visual analogue scale showed consistent and sustained increases from baseline with sutimlimab treatment. Following a 9-week washout, all PROs approached baseline values. Continued inhibition of the classical complement pathway with sutimlimab results in meaningful long-term improvements in PROs (fatigue and QoL) in patients with CAD. Sanofi.

Poster 203: Staged Hip Arthroscopy and Periacetabular Osteotomy Versus Hip Arthroscopy Alone in Patients with Borderline Hip Dysplasia: A Propensity-Matched Study

Objectives: The management of borderline hip dysplasia (BHD) remains an area of interest in the field of hip preservation. The purpose of this study was to (1) evaluate mean 2-year outcomes for patients with BHD treated with staged hip arthroscopy and periacetabular osteotomy (PAO) to those who underwent hip arthroscopy alone, and (2) evaluate rates of complications, hardware removal, reoperations, conversions to total hip arthroplasty (THA), along with conversions to PAO. Methods: Hips with a lateral center-edge angle (LCEA) values 18° ≤ LCEA &lt; 25° that underwent a hip arthroscopy for femoroacetabular impingement syndrome (FAIS) between January 2018 and June 2022 were reviewed. Patients who underwent staged periacetabular osteotomy and hip arthroscopy were identified. Staged hips were propensity-matched 1:4 to other borderline dysplastic hips that underwent hip arthroscopy alone. Matching was performed based on age, sex, and body-mass index (BMI). Patient-reported outcomes (PROs) were collected, including Hip Outcome Score – Activities of Daily Living (HOS-ADL), HOS-Sports Specific (HOS-SS) subscale, 12-item International Hip Outcome Tool (iHOT-12) questionnaire, Patient-Reported Outcomes Measurement Information System-Pain Interference (PROMIS-PI) subscale, and PROMIS-Physical Function (PROMIS-PF) subscale. Cohort-specific minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS) thresholds were calculated. Postoperative PROs, rates of MCID/PASS achievement, and rates of reoperation and conversion to THA were compared. Results: Twenty-four patients who underwent staged hip arthroscopy and PAO were successfully matched to 96 patients who underwent hip arthroscopy alone. Both groups were similar in terms of age, sex, and BMI. The patients who underwent a PAO had smaller LCEAs and larger Tönnis angles (21.0° vs. 23° and 11.6° vs. 9.1°, respectively). Both groups demonstrated significant improvement in PROs at minimum 1-year postoperatively (p &lt; 0.001, for all). There were no significant differences in postoperative PRO scores between the groups (p ≥ 0.223, for all). There were no significant differences in MCID/PASS achievement (p ≥ 0.224. for all). There were no reoperations or conversion to THA in the staged hip arthroscopy and PAO group. In the hip arthroscopy alone cohort, reoperation rates were 5.2% and conversion to THA occurred in 1% of the patients. There were no significant differences in secondary surgery rates between the groups (p = 1.000). Three patients in the hip arthroscopy alone group ultimately underwent PAO, 1 underwent a proximal femoral osteotomy (PFO), and one underwent a revision hip arthroscopy. These female patients were young and athletic with an LCEA &lt; 20°. Conclusions: Patients undergoing staged PAO and hip arthroplasty and isolated hip arthroplasty for treatment of BHD demonstrate similar clinical improvement. Rates of revision surgery and conversion to THA were similarly low. A small subset of patients who were initially treated arthroscopically ultimately received a PAO. This group was entirely made up of young, athletic female patients. This is encouraging early data and more long-term data is needed to evaluate the differences in survivorship. [Figure: see text]

The Impact of L4-L5 Minimally Invasive Transforaminal Lumbar Interbody Fusion on 2-Year Adjacent-level Parameters

ObjectiveThis study evaluates the impact of L4-5 minimally invasive surgery (MIS)-TLIF on adjacent-level parameters. MethodsThis is a retrospective study performed on consecutive patients between January 2015–December 2019. The index- and adjacent-level segmental lordosis (SL) and disc angle (DA) were measured. Patient-reported outcomes (PROs) were collected preoperatively and at 3–24 months postoperatively. Factors influencing changes in adjacent-level parameters and the occurrence of adjacent segment degeneration (ASDeg) were assessed. ResultsOne hundred and seventeen adult patients, averaging 65.5 years of age and slight preponderance of female (56.4%), were analyzed. L4-5 SL decreased at 2 years (p<0.05), but L4-5 DA significantly increased at all timepoints (p<0.05). While L3-4 SL and DA significantly decreased at all timepoints (p<0.05), L5-S1 SL decreased at 3 and 12 months (p<0.05) and L5-S1 DA only significantly decreased at 2 years (p<0.05). All PROs improved significantly (p<0.0001). The ASDeg rate was 19.7% at 2.2 years. Cephalad and caudal ASDeg rates were 12.0% and 10.3%, respectively. Eight patients (6.8%) required adjacent-level reoperations, mainly at L3-4 (6 cases). The use of expandable cage significantly reduced the odds of caudal ASDeg (OR 0.15, p=0.037), but had no significant effect on cephalad ASDeg.. ConclusionsL4-5 MIS-TLIF had a more consistent effect on L3-4 than L5-S1. Although adjacent-level SL and DA decreased over time, their association with ASDeg appears limited, suggesting a multifactorial etiology. L4-5 MIS-TLIF provides demonstrable clinical benefits with lasting PRO improvements and low adjacent-level reoperations.

Patients Engaged in Losing Weight Preoperatively Experience Improved Outcomes After Hiatal Hernia Repair.

Adherence to preoperative weight loss recommendations may serve as a surrogate for the level of engagement in hiatal hernia (HH) patients. This study aims to evaluate the relationship between achieving preoperative weight loss goals and outcomes after HH repair. A retrospective review of 235 patients undergoing laparoscopic HH repair at a single institution was performed. Patients were grouped based on the percentage of weight loss goal achieved. Low achievement was defined as the bottom quartile of goal achievement (≤75%); high achievement was defined as the top quartile (≥140%). Baseline characteristics, clinical outcomes, and patient reported outcomes (PROMs) were compared between groups. 131/235 (55.7%) achieved their weight loss goal. No differences in baseline characteristics or clinical outcomes were observed between the low and high achievement groups. While both groups experienced improvements in PROMs postoperatively, patients in the high achievement group demonstrated significantly lower symptom burden at one-month postoperatively. Further, high-achievement patients were more likely to experience complete resolution of common HH symptoms at one-month postoperatively, including no difficulty swallowing food, no breathing difficulties or choking episodes, no choking when eating food, no choking when drinking liquid, and no regurgitation of food or liquid. In patients undergoing laparoscopic HH repair, patients achieving their preoperative weight loss goals experienced less overall symptom burden and lower prevalence of common symptoms one-month postoperatively than those with low levels of goal achievement. These results demonstrate that patients can take an active role in improving their own surgical outcomes and health status.

Telehealth mindful exercise for people with knee osteoarthritis: A decentralized feasibility randomized controlled trial

ObjectiveNegative psychological beliefs like fear avoidance and catastrophizing can interfere with exercise engagement in people with knee osteoarthritis (OA). Mindfulness, when integrated with exercise, could potentially address both psychological and physical impairments. Our objectives were to optimize and assess the feasibility of a novel telehealth, group-based mindful exercise intervention for people with knee OA. MethodsWe conducted a decentralized randomized controlled trial where participants (n ​= ​40) with symptomatic knee OA were randomized into mindful exercise (n ​= ​21) or exercise-only (n ​= ​19) groups. Both groups received supervised group-based interventions weekly for 8-weeks via Zoom. Primary outcomes were safety, fidelity, and feasibility of the mindful exercise intervention. Participants completed patient-reported outcomes (PRO) for pain, function, and psychological measures at baseline, week-8, and week-14. ResultsParticipants were from 21 US states; >90% identified as having White race, 16% were from rural areas, and approximately 40% had an annual income < $50,000. At 8-weeks, mindful exercise and exercise groups had retention rates of 86% (18/21) and 100% (19/19), and attendance was 54% (11.4/21) and 68% (13/19) respectively. There were no adverse events in the mindful exercise group and four in the exercise group related to exacerbation of knee pain. Preliminary findings showed numerically larger improvements in several PROs for the mindful exercise group. ConclusionAn 8-week telehealth, group-based, mindful exercise intervention was safe for people with knee OA. Our decentralized approach was feasible in terms of recruitment and retention. Further refinement is needed to improve intervention attendance and participant diversity.

Long-term Survivorship and Outcomes of Patients Without Dysplasia Undergoing Capsular Repair During Primary Hip Arthroscopy for Femoroacetabular Impingement Syndrome

Background: There is a paucity of literature evaluating long-term outcomes and survivorship of patients undergoing primary hip arthroscopy with capsular repair for femoroacetabular impingement syndrome (FAIS). Purpose: To report 10-year survivorship and patient-reported outcomes (PROs) after primary hip arthroscopy with capsular repair for FAIS and evaluate the effect of capsular repair in patients at the highest risk for conversion to arthroplasty. Study Design: Cohort study; Level of evidence, 3. Methods: Data were prospectively collected and retrospectively reviewed on all patients undergoing primary hip arthroscopy with capsular repair between October 2008 and February 2011. Patients with a minimum 10-year follow-up on the modified Harris Hip Score (mHHS), Nonarthritic Hip Score (NAHS), and visual analog scale for pain (VAS) scores were selected. The preoperative and minimum 10-year follow-up Hip Outcome Score—Sports Specific Subscale (HOS-SSS) scores were also reported, if available. Patients with ipsilateral hip surgery, worker’s compensation, Tönnis osteoarthritis grade >1, and hip dysplasia (lateral center-edge angle <25°) were excluded. Survivorship, PROS, and clinical benefit—minimal clinically important difference (MCID) and Patient Acceptable Symptom State (PASS)—were reported. An additional propensity-matched subanalysis was performed on patients at the highest risk for conversion to arthroplasty, comparing patients undergoing capsular repair to patients with unrepaired capsules. Results: A total of 145 (n = 130 patients) out of 180 eligible hips (n = 165 patients) had a minimum 10-year follow-up (80.6%). Also, 126 hips (86.9%) belonged to women, and 19 hips (13.1%) belonged to men. The mean patient age was 30.3 ± 12.9 years. The survivorship rate was 91% at the 10-year follow-up. The cohort experienced significant improvements (P < .001) in the mHHS, NAHS, HOS-SSS, and VAS for pain scores. Moreover, the cohort achieved high rates of the PASS for the mHHS (89.8%), high rates of the MCID for the mHHS (82.4%), and high rates of the MCID for VAS for pain (80.6%) scores. In the propensity-matched subanalysis performed on patients with the highest risk for arthroplasty, 29 hips with capsular repair were matched to 81 hips with unrepaired capsules. While both groups experienced significant improvements in all PROs (P < .05), the group without capsule repair trended toward a higher conversion to arthroplasty rate when compared with the repair group. In addition, an odds ratio was calculated for the likelihood of converting to arthroplasty after having an unrepaired capsule compared with capsular repair (2.54 [95% CI, 0.873-7.37]; P = .087). Conclusion: Patients undergoing primary hip arthroscopy with capsular repair experienced a high survivorship rate of 91% at a minimum 10-year follow-up. Patients who did not convert to arthroplasty saw favorable improvements in PROs and achieved high clinical benefit rates. In addition, among those patients at the highest risk for conversion to arthroplasty, a trend toward greater survivorship was observed with capsular repair.

Staged Hip Arthroscopy with Labral Repair, Femoroplasty, and Capsular Plication Followed by Periacetabular Osteotomy for Hip Dysplasia Results in Improved Outcomes and 100% Survivorship at Minimum 2-Year Follow-Up

PurposeTo assess patient-reported outcomes (PROs), clinically significant outcomes (CSOs), and survivorship following staged hip arthroscopy with labral repair, femoroplasty, and capsular plication followed by periacetabular osteotomy (PAO) for the management of femoroacetabular impingement syndrome (FAIS) and hip dysplasia (lateral center edge angle ≤25°). MethodsA prospectively maintained database was queried to retrospectively identify patients who underwent staged primary hip arthroscopy and PAO between 1/2018–10/2021 and had a minimum 2-year follow-up. PROs collected included, Hip Outcome Score Activities of Daily Living/Sports Subscale (HOS-ADL/SS), international Hip Outcome Tool-12 item questionnaire (iHOT-12), and Visual Analog Scale for Pain (VAS Pain). CSO achievement for minimal clinical important difference (MCID) and patient acceptable symptom state (PASS) were determined through cohort specific thresholds. Rates of reoperation, including, revision hip arthroscopy and conversion to total hip arthroplasty (THA) were evaluated to determine short-term survivorship. ResultsThirty-nine hips met criteria for inclusion, of which 35 hips had minimum 2-year follow up (89.7% compliance). Mean age was 25±9.1 years and 91.7% of patients were female. Respective pre- and postoperative radiographic outcomes were: Alpha angle 59.8±5.9 to 39.7±2.6°, Tönnis angle 14.6±5.6° to -1.0±2.9°, lateral center-edge angle 16.6±5.5° to 36.6±4.6°, and anterior center-edge angle 15.6±9.1° to 36.1±3.8°, with statistically significant differences pre- to postoperatively for all (P<0.001). Patients demonstrated significant improvement in all PROs pre- to postoperatively (P ≤0.004). MCID and PASS achievement rates for any PRO were 93.9% and 78.8%, respectively. There were no revision hip surgeries or conversion to THA at a mean 2.7±1.0-year follow-up. Four patients (11.1%) underwent hardware removal. One patient (2.8%) experienced a postoperative infection treated with incision and drainage. ConclusionsStaged hip arthroscopy and PAO for the management of hip dysplasia demonstrated improvement in PROs, high CSO achievement rates, and 100% survivorship at minimum 2-year follow-up.

Health-related quality of life (HRQoL), functioning, and symptoms with odronextamab monotherapy in patients (pts) with relapsed or refractory follicular lymphoma (R/R FL) by POD24 status in the ELM-2 study.

e19057 Background: In ELM-2 (NCT03888105), a Ph 2, single arm, open label trial, odronextamab demonstrated robust efficacy, generally manageable safety, and overall maintenance of patient-reported outcomes (PROs) in R/R FL pts (Villasboas et al. ASH 2023). In FL, pts with disease progression within 2 yrs of frontline chemoimmunotherapy (POD24) are hard to treat with poor clinical outcomes, representing an unmet need. We report PROs by POD24 status in pts with Grade 1–3a R/R FL from ELM-2. Methods: Pts received IV odronextamab in 21-day cycles (C): 80 mg QW in C1–4, with C1 dose step up to mitigate cytokine release syndrome, then 160 mg Q2W (Q4W if complete response ≥9 mo) until progression. PROs were collected at baseline (BL), Wks 2–4, 10, then Q8W in Yr 1, and Q12W in Yr 2. Post-hoc POD24 subgroup analyses were performed on six EORTC QLQ-C30 scales, the EQ-5D-3L VAS, and FACT-Lym LymS. Estimated mean change from BL (CFB) was analyzed using mixed models for repeated measures (MMRM) through Wk 42 (≥10 pts at last assessment). Published meaningful CFB thresholds were used to define deterioration/improvement in responder analyses. Results: By Jan 31, 2023, 140 pts with R/R FL had received odronextamab. Pts with POD24 (n=70) were younger than pts without POD24 (n=70; median age 57.5 vs 62.0 y), had fewer prior Tx lines (median 2 vs 3), and a higher proportion double refractory to anti-CD20 Ab + alkylator (53% vs 29%). Objective response rate was similar in evaluable pts with (n=63; 79%) and without (n=65; 80%) POD24. PRO questionnaire completion ranged from 52–95% through Wk 42 across groups. Descriptive analyses suggest BL PRO scores were similar by POD24 status, showing good HRQoL/functioning and low symptom burden, and were generally maintained through Wk 42 with minimal between-group differences (overlapping 95% CIs for LS mean CFB [Table]). In both groups, more pts reported PRO maintenance or improvement vs deterioration across visits, except for fatigue at Wk 10 in pts without POD24. Conclusions: In pts with heavily pretreated R/R FL, odronextamab Tx maintained HRQoL, functioning, and symptoms irrespective of POD24 status. Clinical trial information: NCT03888105 . [Table: see text]

Improvements in Patient-Reported Outcomes After Treatment With Deucravacitinib in Patients With Psoriatic Arthritis: Results From a Randomized Phase 2 Trial.

Deucravacitinib, a tyrosine kinase 2 inhibitor, was assessed in a phase 2 trial in patients with active psoriatic arthritis (PsA). Here, we report effects of deucravacitinib from the patient perspective. This phase 2, double-blind trial (NCT03881059) randomized patients with active PsA 1:1:1 to deucravacitinib 6 mg once daily (QD), 12 mg QD, or placebo, for 16 weeks. Key secondary end points were changes from baseline (CFBs) at week 16 in Health Assessment Questionnaire-Disability Index (HAQ-DI) and 36-item Short-Form Health Survey (SF-36) physical component summary (PCS) scores. Additional patient-reported outcomes (PROs) assessed disease impact, including fatigue, pain, and mental health. The mean CFBs in PROs and percentages of patients reporting improvements with minimum clinically important differences (MCIDs) or scores of greater than normal values were also assessed. This study comprised 203 patients (51.2% female; mean ± SD age, 49.8 ± 13.5 years). At week 16, the adjusted mean difference (95% confidence interval) versus placebo in HAQ-DI and SF-36 PCS CFB was significant for each deucravacitinib group (HAQ-DI 6 mg, -0.26 [-0.42 to -0.10], P = 0.0020; HAQ-DI 12 mg, -0.28 [-0.45 to -0.12], P = 0.0008; SF-36 PCS 6 mg, 3.3 [0.9 to 5.7], P = 0.0062; SF-36 PCS 12 mg, 3.5 [1.1 to 5.9], P = 0.0042). MCID at week 16 were reported for all PROs with either dose of deucravacitinib. Improvements of MCID or to normative values were reported by more patients receiving deucravacitinib than placebo. Deucravacitinib groups demonstrate significant and clinically meaningful improvements in PROs versus placebo in patients with active PsA, which warrants further study.

Rapid and sustained improvements in itch and quality of life with upadacitinib plus topical corticosteroids in adults and adolescents with atopic dermatitis: 52-week outcomes from the phase 3 AD Up study

Purpose: Atopic dermatitis (AD) adversely impacts quality of life (QoL). We evaluated the effect of upadacitinib, an oral selective Janus kinase inhibitor approved for moderate-to-severe AD, plus topical corticosteroids (+TCS) on patient-reported outcomes (PROs) over 52 weeks. Materials and methods: In the phase 3 AD Up study (NCT03568318), adults and adolescents with moderate-to-severe AD were randomized 1:1:1 to once-daily upadacitinib 15 mg, 30 mg, or placebo + TCS. Itch, skin pain/symptoms, sleep, QoL, daily activities, emotional state, mental health, and patient impressions of disease severity/improvement/treatment satisfaction were assessed. Results: This analysis included 901 patients. Within 1–2 weeks, PRO improvements were greater with both upadacitinib doses than with placebo (p <.05). Improvements increased through weeks 4–8; rates were generally maintained through week 52. At week 52, the proportion of patients with clinically meaningful improvements in itch (Worst Pruritus Numerical Rating Scale improvement ≥4), skin pain (AD Symptom Scale Skin Pain improvement ≥4), sleep (AD Impact Scale [ADerm-IS] Sleep improvement ≥12), daily activities (ADerm-IS Daily Activities improvement ≥14), and emotional state (ADerm-IS Emotional State improvement ≥11) ranged from 62.1%–77.7% with upadacitinib 15 mg + TCS and 71.3%–83.6% with upadacitinib 30 mg + TCS. Conclusions: Upadacitinib + TCS results in rapid, sustained improvements in burdensome AD symptoms and QoL.

Upadacitinib Rapidly Improves Patient-Reported Outcomes in Atopic Dermatitis: 16-Week Results from Phase3 Clinical Trials (Measure Up1 and 2).

Atopic dermatitis (AD) is characterized by intense itch and other symptoms that negatively impact quality of life (QoL). This study evaluates the effect of upadacitinib (an oral selective Janus kinase inhibitor) monotherapy on patient-reported outcomes (PROs) among adults and adolescents with moderate-to-severe AD over 16weeks. This integrated analysis of the double-blind, placebo-controlled periods of phase3 monotherapy clinical trials Measure Up1 (NCT03569293) and Measure Up2 (NCT03607422) assessed itch (Worst Pruritus Numerical Rating Scale [WP-NRS] and SCORing Atopic Dermatitis [SCORAD]), skin pain and symptom severity (AD Symptom Scale), symptom frequency (Patient-Oriented Eczema Measure), sleep (AD Impact Scale [ADerm-IS] and SCORAD), daily activities and emotional state (ADerm-IS), QoL (Dermatology Life Quality Index [DLQI] and Children's DLQI), mental health (Hospital Anxiety and Depression Scale), and patient impressions (Patient Global Impression of Severity, Patient Global Impression of Change, and Patient Global Impression of Treatment). Data from 1683 patients (upadacitinib 15mg, n = 557; upadacitinib 30mg, n = 567; placebo, n = 559) were analyzed. A greater proportion of patients receiving upadacitinib versus placebo experienced improvements in itch (≥ 4-point improvement on WP-NRS) by week1 (upadacitinib 15mg, 11.2%; upadacitinib 30mg, 17.7%; placebo, 0.5%; P < 0.001), with response rates sustained through week16 (upadacitinib 15mg, 47.1%; upadacitinib 30mg, 59.8%; placebo, 10.4%; P < 0.001). Improvements were similar for PROs assessing skin pain/symptoms, sleep, daily activities, QoL, emotional state, mental health, and patient impressions of disease severity and treatment. Responses generally improved rapidly (within 1-2weeks), increased through weeks 4-6, and were maintained through week16. Once-daily oral upadacitinib monotherapy improved response rates across PROs compared with placebo. Upadacitinib therapy resulted in rapid, sustained improvements in PROs measuring symptom burden and QoL in adults and adolescents with moderate-to-severeAD. ClinicalTrials.gov identifiers, NCT03569293 and NCT03607422.