Improvements In Patient-reported Outcomes Research Articles

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.

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.

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.

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.

OA11 Maintained improvement in patient reported outcomes in early axial spondyloarthritis following certolizumab pegol dose reduction

Abstract Background/Aims Certolizumab pegol (CZP), a PEGylated TNFi without an Fc region, has previously shown efficacy and safety in patients with axial spondyloarthritis (axSpA). EULAR guidelines recommend that tapering of a biologic can be considered for patients in sustained remission. The C-OPTIMISE trial (NCT02505542) identified early (&amp;lt;5 years) axSpA patients in sustained remission who may benefit from dose tapering or stopping treatment. Here we report whether a reduced CZP maintenance dose is associated with sustained improvements in patient reported outcomes (PROs) in patients with axSpA at Week (Wk) 96. Methods C-OPTIMISE was a two-part, multicentre, phase 3b study in adult patients. Part A: up to Wk48 (open-label), patients received CZP 200mg Q2W. At Wk48 (Part B), patients who achieved sustained remission at Wk32 or 36 (ASDAS &amp;lt;1.3), were randomised 1:1:1 to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg Q4W (reduced maintenance dose), or placebo (PBO [drug withdrawal]) for additional 48Wks. We report disease activity and PROs (BASDAI, PtGADA, nocturnal apinal pain, morning stiffness, fatigue, and ASQoL) during Part B (Wks48-96). Flare is defined as ASDAS ≥2.1 at two consecutive visits, or ASDAS &amp;gt;3.5 at any visit. Results At Wk48 (Part A), 43.9% (323/736) of patients achieved sustained remission, of which 313 patients were randomised to Part B (Wks48-96). During Wks48-96, 87/104 (83.7%) patients receiving the full maintenance dose, 83/105 (79.0%) patients receiving the reduced maintenance dose, and 21/104 (20.2%) patients receiving PBO remained flare-free. Patients receiving full maintenance and those on reduced dose have similar disease activity measures (BASDAI; mean [SD], 0.8 [0.8] vs 0.8 [1.0]) at Wk96 (Table). Sustained improvements in PROs were similar for CZP full maintenance dose and CZP reduced maintenance dose, including ASQoL, fatigue and nocturnal spinal pain, while PBO showed increased disease activity (Table). Conclusion In axSpA patients who achieved sustained remission, CZP reduced dosage resulted in sustained improvements in disease activity and PROs similar to those receiving full maintenance dose. This suggests that dose reduction can be a viable strategy without compromising PROs. Disclosure A. Chan: Member of speakers’ bureau; AC has received speaker bureau from Novartis, UCB, Abbvie, Janssen, Amgen. Grants/research support; AC has received grant support for service and educational projects from Novartis and UCB Pharma. Other; AC has received honoraria/advisory boards from Novartis, Abbvie, UCB, Janssen, Amgen, Lilly. J. Wood: Other; JW is an employee of UCB Pharma. L. Burns: Other; LBu is an employee of UCB Pharma. R. Tham: Other; RT is employed by Veramed and a contractor for UCB Pharma. T. Kumke: Other; TK is an employee and shareholder of UCB Pharma. B. Hoepken: Other; BH is an employee and shareholder of UCB Pharma. M. Kim: Other; MK is an employee of UCB Pharma. L. Bauer: Other; LBa is an employee and shareholder of UCB Pharma. K. MacKay: Other; KM received consultancy &amp; speaker meetings for UCB, AbbVie, Novartis, Lilly, AZ, Janssen and Roche. K. Gaffney: Shareholder/stock ownership; KG is a shareholder of Rheumatology Events. Grants/research support; KG has received grants/research support from NASS, Versus Arthritis, AbbVie, Pfizer, UCB Pharma, Norvartis, Eli Lilly, Cellgene, Celltrion, Janssen, Gilead and Biogen. Other; KG has received honoraria/ consultation fees from Novartis, AbbVie, UCB Pharma, Lilly and Pfizer, KG has received speaker’s bureau from Novartis, UCB Pharma, AbbVie and Lilly; meeting expenses from AbbVie, Lilly, Roche, Novartis, Pfizer and UCB Pharma.

Treating moderate-to-severe menopausal vasomotor symptoms with fezolinetant: analysis of responders using pooled data from two phase 3 studies (SKYLIGHT 1 and 2).

The aims of the study were to further characterize the efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause using responder analysis and to investigate whether efficacy, not adjusted for placebo, resulted in clinically meaningful within-patient change. This prespecified analysis used pooled data from two phase 3, randomized, double-blind, placebo-controlled studies (SKYLIGHT 1 and 2). Responders were those experiencing ≥50%, ≥75%, ≥90%, or 100% reduction in VMS frequency from baseline to weeks 4 and 12. Responder analysis was performed for patient-reported outcome (PRO) measures to evaluate participants achieving a clinically meaningful within-patient change (not placebo adjusted) at week 4 and 12 versus baseline. Single responders were based on outcomes of VMS frequency, Patient-Reported Outcomes Measurement Information System Sleep Disturbance-Short Form 8b Total Score, Menopause-Specific Quality of Life (MENQoL) Total Score, and MENQoL VMS Domain Score. Double and triple responder analyses combined VMS frequency plus one or more of the PRO. Patient Global Impression of Change VMS was deemed a suitable anchor measure for meaningful within-patient change in VMS frequency. A greater proportion of fezolinetant-treated versus placebo-treated participants had ≥50%, ≥75%, ≥90%, or 100% reduction in VMS frequency from baseline to weeks 4 and 12. A greater proportion of responders were observed in the fezolinetant groups versus placebo at week 12 in all four single responder analyses. In the double and triple responder analyses, odds ratios were supportive of a beneficial effect for both doses of fezolinetant versus placebo. Fezolinetant was associated with significantly higher within-patient clinically meaningful improvement in important PRO, including VMS frequency, PROMIS SD SF 8b Total Score, MENQoL Total Score, and MENQoL VMS Domain Score.

Patient-reported outcome differences for navigated and robot-assisted total hip arthroplasty frequently do not achieve clinically important differences: a systematic review.

Total hip arthroplasty (THA) using computer-assisted navigation (N-THA) and robot-assisted surgery (RA-THA) has been increasingly adopted to improve implant positioning and offset/leg-length restoration. Whether clinically meaningful differences in patient-reported outcomes (PROMs) compared to conventional THA (C-THA) are achieved with intraoperative technology has not been established. This systematic review aimed to assess whether published relative PROM improvements with technology use in THA achieved minimal clinically important differences (MCIDs). PubMed/MEDLINE/Cochrane Library were systematically reviewed for studies comparing PROMs for primary N-THA or RA-THA with C-THA as the control group. Relative improvement differences between groups were compared to established MCID values. Reported clinical and radiographic differences were assessed. Review of N-THA and RA-THA literature yielded 6 (n = 2580) and 10 (n = 2786) studies, respectively, for analyses. Statistically significant improvements in postoperative PROM scores were reported in 2/6 (33.3%) studies comparing N-THA with C-THA, though only 1 (16.7%) reported clinically significant relative improvements. Statistically significant improvements in postoperative PROMs were reported in 6/10 (60.0%) studies comparing RA-THA and C-THA, though none reported clinically significant relative improvements. Improved radiographic outcomes for N-THA and RA-THA were reported in 83.3% and 70.0% of studies, respectively. Only 1 study reported a significant improvement in revision rates with RA-THA as compared to C-THA. Reported PROM scores in studies comparing N-THA or RA-THA to C-THA often do not achieve clinically significant relative improvements. Future studies reporting PROMs should be interpreted in the context of validated MCID values to accurately establish the clinical impact of intraoperative technology.

Safety and efficacy of second-generation all-suture anchors in labral tear arthroscopic repairs: prospective, multicenter, 1-year follow-up study

BackgroundThis study’s primary aim was to assess the safety and performance of second-generation all-soft suture anchors following arthroscopic labral tear repair. MethodsThis prospective, multicenter study was conducted by 6 surgeons at 6 sites in Europe and the United States between November 2018 and August 2020. Patients who required shoulder arthroscopic repair, for a range of labral injuries, were treated with a second-generation all-soft suture anchor. The primary outcome was clinical success rate (percentage of patients without signs of failure and/or re-intervention) at 6 months. Secondary outcomes included clinical success rate at 12 months, intraoperative anchor deployment success rate, and patient-reported outcomes (PROs) at 6 and 12 months, including visual analog scale (VAS) pain assessment, VAS satisfaction assessment, EQ-5D-5L Index Score, EQ-5D-5L VAS Health Score, Rowe Shoulder Score for Instability, American Shoulder and Elbow Surgeons score, and Constant-Murley Shoulder (CMS) Score. Serious adverse events (SAE) and serious adverse device effects (SADE) were collected throughout the study. ResultsForty-one patients were enrolled (mean age, 28.2 years; 87.8% male, 12.2% female). Clinical success was achieved in 27/28 and 31/32 patients at 6 months and 12 months, respectively. Anchor deployment had a 100% success rate. Significant improvements over baseline were reported for all PROs except CMS (6 months) and VAS Satisfaction Score (12 months). One patient experienced 1 SAE and 1 patient experienced 1 SADE. ConclusionSecond-generation all-soft suture anchors used in this study demonstrated a high clinical success rate, a favorable safety profile, and patients exhibited significant improvement in PROs.

Outcomes and Quality of Life After Resorbable Synthetic Ventral Hernia Repair in Contaminated Fields.

The ideal mesh type for hernia repair in a contaminated field remains controversial. Data regarding outcomes beyond 1 year and the impact on quality of life (QoL) are unknown. This study aims to evaluate the long-term surgical outcomes and patient-reported outcomes (PROs) after contaminated repair with poly-4-hydroxybutyrate (P4HB) mesh. Patients undergoing a contaminated hernia repair with P4HB between 2015 and 2020 were identified. Surgical site occurrences and hernia recurrences were recorded. Long-term PROs as defined by the Abdominal Hernia-Q and Hernia-Related Quality-of-Life Survey were assessed. Fifty-five patients were included with a mean age of 54.5 years, a body mass index of 34 kg/m2, and a defect size of 356.9 ± 227.7 cm2. Median follow-up time was 49 months with a reoperation rate of 14.5% and a hernia recurrence rate of 7.3%. Of the 55 patients, 37 completed preoperative and postoperative PRO questionnaires. When comparing preoperative with postoperative Abdominal Hernia-Q, there was significant improvement in overall PROs (2.1 vs 3.5, P < 0.001). This improvement was maintained with no significant changes between postoperative scores over the course of 5 years. Patients with complications saw the same improvement in postoperative PRO scores as those without complications. Our study found a low hernia recurrence and acceptable long-term reoperation rates in patients undergoing hernia repair with P4HB mesh in a contaminated setting. We demonstrate a sustained significant improvement in QoL scores after hernia repair. These data yield insight into the long-term outcomes and QoL improvement, providing physicians further knowledge to better counsel their patients.

The Everted Acetabular Labrum: Outcomes of Surgical Management

Background: An everted acetabular labrum (EL) is a pathologic variant in which the labrum is flipped to the capsular side of the acetabular rim. An iatrogenic EL is a known complication of a poorly executed labral repair, and a recent study described the native acetabular EL. Purpose: To analyze surgical outcomes after advancement or reconstruction of an EL in a native hip. Study Design: Cohort study; Level of evidence, 3. Methods: This was a multicenter retrospective review of prospectively collected data on primary hip arthroscopic surgeries performed between 2013 and 2023. An EL was identified arthroscopically as a labrum–femoral head gap while off traction in the native hip. All patients with EL who were analyzed in this study underwent arthroscopic labral repair and advancement or labral augmentation or reconstruction. Patients with hip dysplasia also underwent periacetabular osteotomy with or without a derotational femoral osteotomy. Patient-reported outcomes (PROs) were assessed using the 12-item International Hip Outcome Tool (iHOT-12) and the Nonarthritic Hip Score. PROs were obtained preoperatively and up to 24 months after surgery. PROs were compared with those of a case-matched control cohort in a 1:2 ratio. Only patients with PROs available at ≥1 year postoperatively were included in the outcome analysis. Results: A total of 111 patients (129 hips) with EL during the study period were identified, with PROs available in 96 hips. The mean age of patients with EL was 30.5 years, and women made up 87% of the cohort. Of the 129 hips with an EL, an isolated diagnosis of an EL was present in 11.6% of hips. Deficient acetabular coverage (lateral center-edge angle <25°) was seen in 40.6% of EL hips. No difference was seen in iHOT-12 scores between EL and control groups at 12- or 24-month follow-up (P = .18 and .94, respectively). Patients with EL reported a significant improvement of PROs at latest follow-up (P < .001 for iHOT-12 and Nonarthritic Hip Score). Conclusion: Surgical management of a native EL with restoration of the labral seal on the femoral head and correction of concomitant pathologies resulted in significant clinical improvement, with postoperative outcome scores comparable to those of patients without an EL. These findings provide evidence supporting surgical intervention for a native EL.

Real-World Effectiveness of Upadacitinib for Treatment of Rheumatoid Arthritis in Canadian Patients: Interim Results from the Prospective Observational CLOSE-UP Study.

Upadacitinib (UPA), a selective, reversible, oral Janus kinase (JAK)-1 inhibitor, was approved in 2019 in Canada for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). This phase4 prospective study aimed to characterise the effectiveness of UPA in the real-world population of patients with RA. Adults with RA who initiated treatment with once daily UPA (15mg) and enrolled in the Canadian Real-Life post-marketing Observational Study assessing the Effectiveness of UPadacitinib for treating rheumatoid arthritis (CLOSE-UP) and who completed a 6-month assessment as of 28 February 2023 were included. The primary endpoint of the CLOSE-UP study is the proportion of patients achieving a Disease Activity Score-28 Joint Count C-reactive protein (DAS28-CRP) < 2.6 at 6months. Data was collected at routine visits. Data analysed and summarised descriptively for the overall interim population and for subgroups based on prior therapy included remission or low disease activity, patient-reported outcomes (PROs), and adverse events. A total of 392 patients were included in the interim analysis. Overall, 63.5% (191/301) of patients achieved a DAS28-CRP score < 2.6 at month6, with similar rates observed for all subgroups analysed according to prior therapy including those with prior JAK inhibitor exposure (range 57.4-71.0%), and in patients who received UPA monotherapy (71.6% [48/67]). Early (month3) and sustained improvements up to 6months were observed for all PROs. The safety profile was consistent with previous reports. Real-world improvements in disease activity and PROs in response to UPA treatment were consistent with clinical trial data across a range of Canadian patients with prior therapy exposure and with UPA monotherapy, with an overall favourable benefit-risk profile. NCT04574492.

Association of 5-Year Hip Arthroscopy Outcomes with Hip Morphology and Cartilage Status at Time of Surgery: A National Registry Study With HAGOS Outcomes in 281 Patients With Femoroacetabular Impingement Syndrome.

The effects of specific bony hip morphologies, cam and dysplasia, and cartilage damage on mid- and long-term (≥5 years) patient-reported outcomes (PROs) are understudied. To investigate if changes in PROs from preoperatively to 5 years after hip arthroscopy are associated with preoperative bony hip morphology and cartilage status in patients with femoroacetabular impingement syndrome. Cohort study; Level of evidence, 3. Patients were identified in the Danish Hip Arthroscopy Registry. Hip and groin function was assessed from preoperatively to 5 years postoperatively with the Copenhagen Hip and Groin Outcome Score (HAGOS) Activities of Daily Living (ADL) and Sports and Recreation (Sport) subscales. Morphology was defined using the anterior alpha angle (AA) and lateral center-edge angle (LCEA) as follows: mild to moderate cam (55°≤ AA < 78°), severe cam (AA ≥ 78°), pincer (LCEA > 39°), and borderline dysplasia (20°≤ LCEA < 25°). Joint space width (JSW) was defined as slightly reduced (3.1 mm ≤ JSW ≤ 4 mm) or severely reduced (2.1 mm ≤ JSW ≤ 3 mm). Acetabular cartilage status was defined by modified Beck grades 0 to 4 and femoral head cartilage status by International Cartilage Regeneration & Joint Preservation Society grades 0 to 4. Acetabular and femoral cartilage injury areas were categorized as <1, 1 to 2, or >2 cm2. Multiple regression analyses assessed adjusted associations between hip morphology and cartilage injuries with improvement in HAGOS-ADL and HAGOS-Sport. The study included 281 patients (age, 35 ± 10 years; 52.3% female). No cam and mild-to-moderate cam were associated with greater improvement in HAGOS-ADL (16 points [P = .002] and 7 points [P = .038], respectively) compared with severe cam. Normal JSW was associated with greater improvement in HAGOS-ADL (21 points; P = .026) compared with severely reduced JSW. Femoral head cartilage injury area <1 cm2 was associated with greater improvements in HAGOS-ADL (17 points; P = .03) and HAGOS-Sport (21 points; P = .035) compared with femoral cartilage injury area >2 cm2. Patients having no-to-moderate cam morphology, normal JSW, or femoral head cartilage injury area <1 cm2 had greater improvement in PROs 5 years after hip arthroscopy compared with patients having severe cam morphology, severely reduced JSW, or femoral cartilage injury area >2 cm2.

Use of a fluoroscopy-based robotic-assisted total hip arthroplasty system produced greater improvements in patient-reported outcomes at one year compared to manual, fluoroscopic-assisted technique

IntroductionThe adoption of new technology should be supported by improvements in patient-reported outcomes (PROMs). The purpose of this study was to assess the one-year PROMs of patients who underwent total hip arthroplasty (THA) using a novel, fluoroscopy-based, robotic-assisted (RA-THA) system when compared to a manual, fluoroscopic-assisted technique (mTHA).Materials and methodsA review of 91 consecutive mTHA and 85 consecutive RA-THA via a direct anterior approach was conducted. All cases were performed by the same surgeon at the same institution, for a pre-operative diagnosis of osteoarthritis, avascular necrosis, or rheumatoid arthritis. Outcomes included one-year Veterans RAND-12 (VR-12) Physical/Mental, Hip Disability and Osteoarthritis Outcome (HOOS) Pain/Physical Function/Joint Replacement, and University of California Los Angeles (UCLA) Activity scores, as well as the difference between pre-operative and one-year post-operative PROMs.ResultsPatients in the RA-THA cohort had lower pre-operative HOOS-JR scores compared to patients in the mTHA cohort (37.0 vs. 43.1; p = 0.031). Cohorts experienced similar one-year post-operative VR-12, HOOS, and UCLA Activity scores. Patients in the RA-THA cohort experienced greater improvements across all pre- and post-operative HOOS scores compared to patients in the mTHA cohort: Pain (+ 54.7 vs. +42.1; p = 0.009), Physical Function (-41.6 vs. -28.7; p = 0.007), and Joint Replacement (+ 46.6 vs. +33.0; p = 0.002). These differences exceeded minimum clinically important difference (MCID).ConclusionsBoth manual and robotic cohorts experienced benefit from THA at one-year post-operative. Importantly, the use of a novel, fluoroscopy-based robotic assistance system for primary THA resulted in greater improvements in PROMs at one-year relative to manual technique.

Minimum 10-Year Outcomes of Matrix-Induced Autologous Chondrocyte Implantation in the Knee: A Systematic Review.

Matrix-induced autologous chondrocyte implantation (MACI) is an established cell-based therapy for the treatment of chondral defects of the knee. As long-term outcomes are now being reported in the literature, it is important to systematically review available evidence to better inform clinical practice. To report (1) subjective patient-reported outcomes (PROs) and (2) the rate of graft failure, reoperation, and progression to total knee arthroplasty (TKA) after undergoing MACI of the knee at a minimum 10-year follow-up. Systematic review; Level of evidence, 4. A comprehensive search of Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily; Ovid Embase; Ovid Cochrane Central Register of Controlled Trials; Ovid Cochrane Database of Systematic Reviews; and Scopus from 2008 to September 15, 2022, was conducted in the English language. Study eligibility criteria included (1) full-text articles in the English language, (2) patients undergoing a MACI within the knee, (3) clinical outcomes reported, and (4) a minimum 10-year follow-up. In total, 168 patients (99 male, 69 female; mean age, 37 years [range, 15-63 years]; mean body mass index, 26.2 [range, 18.6-39.4]) representing 188 treated chondral defects at a minimum 10-year follow-up after MACI were included in this review. Significant and durable long-term improvements were observed across multiple PRO measures. Follow-up magnetic resonance imaging (MRI), when performed, also demonstrated satisfactory defect fill and an intact graft in the majority of patients. The all-cause reoperation rate was 9.0%, with an overall 7.4% rate of progression to TKA at 10 to 17 years of follow-up. At a minimum 10-year follow-up, patients undergoing MACI for knee chondral defects demonstrated significant and durable improvements in PROs, satisfactory defect fill on MRI-based assessment, and low rates of reoperation and TKA. These data support the use of MACI as a long-term treatment of focal cartilage defects of the knee.

Etanercept in Axial Spondyloarthritis, Psoriatic Arthritis, and Plaque Psoriasis: Real-World Outcome Data from German Non-interventional Study ADEQUATE.

For chronic diseases such as axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and plaque psoriasis (PsO), treatment goals include remission or at least low disease activity (LDA) by 12weeks. Improvements in symptoms such as pain and fatigue should also be treatment goals. ADEQUATE was a German, prospective, non-interventional study to evaluate the proportion of patients with rheumatoid arthritis, PsA, axSpA, or PsO who, in routine clinical practice, benefit from the continuation of treatment with etanercept (ETN) beyond 12weeks, even when their treatment goals have not yet been reached. Patient-reported outcomes (PROs) and changes in concomitant glucocorticoid use were also recorded. This article focuses on results for patients with axSpA and PsA; data for patients with PsO are described briefly. In total, 305, 254, and 70 patients with axSpA, PsA, and PsO, respectively, were included. Rates of remission at week12 and week24, respectively, were 19% and 18% for axSpA, 38% and 51% for PsA, and 7% and 19% for PsO. Rates of LDA at week12 and week24, respectively, were 39% and 45% for axSpA, 50% and 60% for PsA, and 34% and 51% for PsO. Extending treatment up to 52weeks was associated with stable rates of or further increases in remission and LDA rates. Improvements in pain, fatigue, and depression (axSpA, PsA, and PsO) and reductions in concomitant glucocorticoid use (axSpA and PsA) were observed. No new safety signals were detected. These findings confirm the effectiveness and safety of ETN in routine clinical practice for several indications and highlight potential benefits of continuing ETN treatment in patients who have not reached their treatment goals after 12weeks. Additional benefits included improvements in PROs and reduction of concomitant glucocorticoids. ClinicalTrials.gov NCT02486302.

Hip Arthroscopy in Recreational Athletes: Risk Factors For Failure to Return to Sport and Factors That Influence Psychological Readiness to Return to Sport

Objective: High level athletes achieve high rates of return to play and improved patient reported outcomes (PROMs) after hip arthroscopy for femoroacetabular impingement (FAI). However, few studies have evaluated return to sport rates in recreational athletes, risk factors for failure to return to sport, and the effect of psychological readiness to return to sport (RTS) within this population. We hypothesize that recreational athletes undergoing hip arthroscopy for FAI achieve high PROMs and rates of RTS and that psychological readiness is a risk factor for failure to RTS. Additionally, we hypothesize that male athletes and younger age are positively associated with psychological readiness to RTS. Methods: Retrospective review of prospectively collected data in our institution's Center for Hip Pain and Preservation Outcomes Registry identified recreational athletes with a minimum of 12 months follow-up, who underwent hip arthroscopy for FAI between 2008-2018. The primary outcome was RTS. The secondary outcomes were ---Hip-RSI (SF) score, modified Harris Hip Score (mHHS), Hip Outcome Score Activities of Daily Living (HOS-ADL), Hip Outcome Score Sport (HOS-Sport), and International Hip Outcome Tool (iHOT33). Results: 84.8% of recreational athletes returned to sport with 70.52% returning to the same level of play. Athletes who failed to RTS were younger (p-value=0.0427), last participated 9-12 months prior to surgery (32.26%) or had stopped participating in sports altogether (70.97%) (p-value=0.0002 and p-value=0.0013). Hip-RSI Score was a statistically significant predictor of failure to RTS at one and two years respectively (OR 0.915 (95%CI 0.87, 0.962) and OR 0.904 (95%CI 0.818, 0.999)). Increasing age had a positive effect on psychological readiness to RTS (0.5004-point increase in RSI score (p-value=0.0002)) while sex, BMI, additional ipsilateral surgery, and last participation in sport were not predictive of psychological readiness (p-values&gt;0.05). Conclusions: Recreational athletes undergoing hip arthroscopy achieve high rates of RTS, return to the same level of play, and demonstrate significant improvements in PROMs. The Hip-RSI-score was a statistically significant predictor of failure to RTS at 1 and 2 years post operatively. Lastly, higher psychological readiness for return to sport was seen in older recreational athletes undergoing hip arthroscopy for FAI.

Hip arthroscopy is an effective treatment for high-level female athletes

ObjectivesThis study aimed to assess the outcomes of hip arthroscopic surgery in high-level female athletes diagnosed with femoroacetabular impingement (FAI) compared to those with lower levels of sports activity. Additionally, we investigated the effectiveness of patient-reported outcomes (PROs) and the potential ceiling effect as a lack of sensitivity in detecting clinically statistically significant changes in high-level female athletes due to high baseline scores. MethodsWe conducted a retrospective analysis of prospectively collected data from female patients who underwent hip arthroscopy for FAI between January 2016 and August 2022 with a minimum 1-year follow-up. Patients were categorised into two groups: high-level athletes (group A) and low sports activity level (group B). Various PROs, visual analogue scales for pain, and patient satisfaction were assessed preoperatively and postoperatively. Return to sports (RTS) rates were determined based on the patient's reported ability to return to their previous level of sports activity. The minimally clinically important differences (MCIDs) and the Patient-Acceptable Symptomatic State (PASS) analyses were used to evaluate the clinical impact of the Hip Outcome Score-Sport Subscale (HOS-SSS). ResultsA total of 11 high-level female athletes were included in group A, and 22 were included in the low sports activity level group B. Both groups showed significant improvements in PROs, with no significant differences between them. RTS rates were lower in high-level athletes (63.6%) than in low sports activity patients (85.7%). Visual analogue scales for pain improved significantly in both groups. Patient satisfaction was high in both groups, with a median score of 9. The HOS-SSS showed no ceiling effect, and the MCID and PASS analyses indicated that a high proportion of patients in both groups achieved clinically relevant improvement in HOS-SSS. ConclusionHip arthroscopic surgery is effective for FAI treatment in high-level female athletes, with outcomes similar to those in patients with lower sports activity levels. The absence of a ceiling effect in sports-related outcomes suggests that PROs can detect clinically significant changes in high-level female athletes. Although RTS rates were lower in high-level athletes, this difference was not significant. These findings underscore the value of using PROs to evaluate outcomes in female athletes with different sports-activity levels. Level of evidenceIV.