Short-Form Health Survey Physical Component Research Articles

The Surprise Question in Hemodialysis, Frailty, Nutrition, Patient-reported Quality of Life, and All-Cause Mortality: The Osaka Dialysis Complication Study (ODCS)

Rationale & ObjectiveA response “no” (SQ-No) to the surprise question (SQ) of whether a clinician would be surprised if a dialysis patient died in the next 6 months is associated with a higher risk of all-cause death. It is uncertain what domains are intuitively assessed with SQ. We hypothesized that SQ would be assessing the patient’s frailty, malnutrition, or patient-perceived health-related quality of life in a cohort of patients on maintenance hemodialysis. Study DesignCohort study Setting & ParticipantsA multi-center study including 994 patients on maintenance hemodialysis in Japan Predictors1) SQ answered by nurses, 2) frailty by modified Cardiovascular Health Study criteria, 3) malnutrition as evaluated by Geriatric Nutritional Risk Index (GNRI), and 4) patient-perceived health-related quality of life examined by the 36 Item Short-Form Health Survey (SF-36) physical component summary (PCS). OutcomesAll-cause mortality Analytical ApproachCox proportional hazard models ResultsMedian age and dialysis vintage were 66 and 5.9 years, respectively, and 35.8% were female, and 39.6% had diabetic kidney disease. The prevalence of SQ-No and frailty was 19.7% and 45.9%. Medians GNRI and SF-36 PCS were 96.3 and 36.9, respectively. During follow-up for 5 years, 247 patients died. Each of SQ-No, being frail, a low GNRI, and a low SF-36 PCS was a significant predictor of a higher risk for mortality independent of potential confounders. SQ-No remained a significant predictor after further adjustment for frailty or GNRI, but SQ-No was no longer significant when adjusted for SF-36 PCS. LimitationsWe did not assess the agreement of responses to SQ between different raters. ConclusionsPredictive ability of SQ was closely related to SF-36 PCS in hemodialysis patients. SQ by nurses appears to assess the physical domain of patient-perceived health-related quality of life rather than objectively assessed frailty or malnutrition.

Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials.

Patterns of treatment response can inform clinical decision-making. This study assessed the course and impact of achieving minimal clinically important improvement (MCII) in clinical measures and patient-reported outcomes (PROs) with guselkumab in patients with active psoriatic arthritis (PsA). Post hoc analyses evaluated 1120 patients with PsA receiving guselkumab every 4or8weeks (Q4W/Q8W) or placebo from DISCOVER-1 (31% tumor necrosis factor inhibitor-experienced) and DISCOVER-2 (biologic-naïve). Achievement of MCII in clinical Disease Activity Index for PsA (cDAPSA), patient global assessment (PtGA) of arthritis, PtGA of psoriasis, patient-reported pain, Functional Assessment of Chronic Illness Therapy-Fatigue, Health Assessment Questionnaire-Disability Index, 36-item Short-Form Health Survey Physical Component Summary score, PtGA Arthritis + Psoriasis, and PsA Disease Activity Score (PASDAS) was compared between the guselkumab and placebo groups using Cox regression. Logistic regression adjusting for baseline factors evaluated associations between early (W4/W8) MCII achievement and stringent response (≥%50/%70 improvement in American College of Rheumatology response criteria, cDAPSA low disease activity [LDA], PASDAS LDA, and minimal disease activity) at W24/W52 among guselkumab-randomized patients. Among patients with highly active PsA (baseline cDAPSA = 44.1-45.0, PASDAS = 6.4-6.5), times to MCII were significantly faster for guselkumab vs. placebo (hazard ratios 1.3-2.5; P < 0.05). Across measures, at first timepoint assessed, MCII rates were significantly higher with guselkumab (Q4W/Q8W 28-68%/29-65%) vs. placebo (19-47%; both P < 0.05). Early (W4/W8) MCII with guselkumab associated with higher odds of achieving stringent responses at W24/W52 (odds ratios 1.4-17.2/1.4-5.4). In a mixed PsA population, significant proportions of patients treated with guselkumab achieved early (W4/W8) MCII across clinical and PRO measures, which associated with ahigher likelihood of attaining clinically relevant improvements and low levels of disease activity at W24/W52. DISCOVER-1 (NCT03162796). DISCOVER-2 (NCT03158285).

Outcome clusters and their stability over 1 year in patients with SLE: self-reported and performance-based cognitive function, disease activity, mood and health-related quality of life

ObjectiveTo determine if self-reported fatigue, anxiety, depression, cognitive difficulties, health-related quality of life, disease activity scores and neuropsychological battery (NB) cluster into distinct groups in patients with SLE based on...

Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study

BackgroundTumor necrosis factor inhibitors (TNFi) are frequently chosen as the first biologic for patients with psoriatic arthritis (PsA). Given that many patients with PsA are TNFi inadequate responders (TNF-IR; either inadequate efficacy or intolerance), treatments utilizing alternative mechanisms of action are needed. In phase 3 studies, the fully human interleukin (IL)-23p19 subunit-inhibitor, guselkumab, was efficacious in patients with active PsA, including TNFi-IR. Efficacy was generally consistent between TNFi-naïve and TNFi-experienced cohorts; however, in the latter, higher response rates have been observed with the Q4W dosing regimen relative to the Q8W dosing regimen for some endpoints, suggesting the need to evaluate whether more frequent dosing may provide an incremental clinical benefit for TNFi-IR patients.MethodsThe phase 3b SOLSTICE study will assess guselkumab efficacy and safety in TNFi-IR PsA patients. Eligibility criteria include a PsA diagnosis for ≥ 6 months; active disease (≥ 3 swollen, ≥ 3 tender joints, C-reactive protein ≥ 0.3 mg/dL); and inadequate efficacy with, and/or intolerance to, one prior TNFi. Participants will be randomized 1:1:1 to guselkumab Q4W or Q8W or placebo→guselkumab Q4W (at Week 24). The primary endpoint is the proportion of patients achieving ≥ 20% improvement in the American College of Rheumatology criteria (ACR20) at Week 24. Major secondary endpoints include ACR50, ACR70; an Investigator’s Global Assessment (IGA) of psoriasis score of 0/1 plus ≥ 2-grade reduction and ≥ 90% improvement in Psoriasis Area and Severity Index (both among patients with ≥ 3% body surface area affected by psoriasis and baseline IGA ≥ 2); minimal/very low disease activity; and changes from baseline in Health Assessment Questionnaire-Disability Index, the 36-item Short-Form Health Survey Physical Component Summary, and Functional Assessment of Chronic Illness Therapy-Fatigue scores. The target sample size (N = 450) is estimated to provide > 90% power in detecting differences between each guselkumab group and the placebo group for the primary endpoint assuming a 2-sided α = 0.05. Cochran-Mantel–Haenszel testing and analyses of covariance will be used to compare efficacy for binary and continuous endpoints, respectively.DiscussionFindings from the phase 3b SOLSTICE study, the design of which was informed by results from previously conducted phase 3 studies, is expected to provide important efficacy and safety information on guselkumab therapy in TNFi-IR patients with PsA.Trial registrationThis trial was registered at ClinicalTrials.gov, NCT04936308, on 23 June 2021.

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.

Gender Differences in Pain, Function, and Quality of Life Five Years Following Primary Total Knee Arthroplasty

BackgroundMultiple authors have sought to determine what patient characteristics influence outcomes after total knee arthroplasty (TKA). The impact of gender on outcomes after TKA remains controversial. Previous studies had less than 5 years of follow-up after TKA. The aim of this evaluation was to determine what differences in pain, function, and quality of life (QoL) exist between female and male patients 5 years after primary TKA. MethodsA prospective, multicenter cohort of 11,602 unilateral primary TKA patients (7,284 females and 4,318 males) was prospectively evaluated. All patients were enrolled in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement. Demographic data, musculoskeletal and medical comorbid conditions, and patient-reported outcome measures, including the Knee Injury and Osteoarthritis Outcome (KOOS) and Short-Form (36-item) Health Survey mental component score (MCS) and physical component score (PCS) were collected preoperatively and at 5 years after TKA. Descriptive statistics were generated, and stratified by gender, and differences in pain, function, and QoL between female and male patients were evaluated. Multivariate regression models with a 95% confidence interval (CI) were used to assess the role of patient gender as a predictive factor for KOOS pain and function in daily living (ADL) scores reported 5 years after primary TKA, while adjusting for other variables. ResultsPrior to surgery, female patients reported worse pain (KOOS pain 46 versus 52), function (KOOS ADL 53 versus 59), and QoL (KOOS QoL 26 versus 29) than male patients. The differences in preoperative scores ranged from 2.70 (KOOS QoL) to 6.12 (KOOS ADL). At 5 years after TKA, female patients reported slightly worse pain (87 versus 89), function (85 versus 87), and QoL (74 versus 75) when compared to male patients. The differences in the mean 5-year postoperative KOOS scores (range, 0.99 to 2.73), although statistically significant (P < .001), were clinically negligible. Female patients achieved greater improvement in pain (41 versus 37), function (32 versus 29), and QoL (48 versus 46) scores in comparison to male patients. Female patients also reported lower preoperative PCS global function (33 versus 35) scores, 5-year postoperative PCS scores (45 versus 46), and MCS global mental function scores (52 versus 54). Similarly, the differences in the 5-year postoperative Short-Form (36-item) Health Survey MCS and PCS scores were clinically negligible. Multivariate regression analysis showed that female gender was not independently predictive for either pain (β = −1.08; 95% CI [−1.25 to 1.03] [P = .85]) or function (β = 0.64; 95% CI [−0.51 to 1.79] [P = .28]) 5 years after surgery. ConclusionsThere are no clinically significant gender differences in pain, function, or QoL 5 years after TKA. Female patients typically have worse symptoms prior to surgery, improve more than male patients, and end up with pain, function, and QoL scores clinically equal to male patients. These data can enhance the shared decision-making process between female patients and surgeons and assist in setting appropriate patient expectations prior to TKA.

Severe genu varus deformity does not affect enhanced recovery after surgery total knee arthroplasty outcomes.

Enhanced recovery after surgery (ERAS) has been increasingly adopted in orthopaedic surgery. Although not an exclusion criterion, patients undergoing total knee arthroplasty (TKA) with preoperative severe varus deformity may be less likely to be enrolled for ERAS. This study aimed to compare the success of ERAS TKA between patients with severe preoperative varus deformities (≥ 15° varus) and the control group (< 15° varus to 14° valgus). Our secondary aim was to compare postoperative complications and functional outcomes between the two groups. 310 TKAs performed from August 2019 to February 2021 were analyzed with a follow-up of 6 months postoperatively. The primary outcome, ERAS TKA success, was defined as length of hospital stay of < 24h. Other parameters included 30-day postoperative complications and clinical outcomes such as the original Oxford Knee Score (OKS), the Knee Society Knee (KSKS) and Function Score (KSFS), Visual Analog Scale for Pain (VAS-P), 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS). There were 119 patients in the severe deformity group and 191 patients in the control group. There were no significant differences in ERAS success between the severe deformity group and control group, with both groups achieving similarly high rates (> 90%) of ERAS success. There were also no differences in 30-day postoperative complications and 6-month postoperative clinical outcomes. Patients with severe preoperative varus deformity undergoing ERAS TKA achieved high ERAS success rates (> 90%). Genu varum is not a contraindication for ERAS TKA.

Impact of headache frequency and preventive treatment failure on quality of life, disability, and direct and indirect costs among individuals with episodic migraine in the United States.

To evaluate unmet needs among individuals with episodic migraine (EM) in the United States (US). Data are limited on the impact of headache frequency (HF) and preventive treatment failure (TF) on the burden of migraine in the US. A retrospective, cross-sectional analysis of 2019 National Health and Wellness Survey (NHWS) data was conducted from an opt-in online survey that identified respondents (aged ≥18 years) in the US with self-reported physician-diagnosed migraine. Participants were stratified by HF (low: 0-3 days/month; moderate-to-high: 4-14 days/month) and prior preventive TF (preventive naive; 0-1 TF; ≥2 TFs). Comparisons were conducted between preventive TF groups using multivariable regression models controlling for patient demographic and health characteristics. Among individuals with moderate-to-high frequency EM, the NHWS identified 397 with ≥2 TFs, 334 with 0-1 TF, and 356 as preventive naive. The 36-item Short-Form Health Survey (version 2) Physical Component Summary scores were significantly lower among those with ≥2 TFs, at a mean (standard error [SE]) of 41.4 [0.8] versus the preventive-naive 46.8 [0.9] and 0-1 TF 44.5 [0.9] groups; p < 0.001 for both). Migraine Disability Assessment Scale scores were significantly higher in the ≥2 TFs, at a mean (SE) of 37.7 (3.9) versus preventive-naive 26.8 (2.9) (p < 0.001) and 0-1 TF 30.1 (3.3) (p = 0.011) groups. The percentages of time that respondents experienced absenteeism (mean [SE] 21.6% [5.5%] vs. 13.4% [3.6%]; p = 0.022), presenteeism (mean [SE] 55.0% [8.3%] vs. 40.8% [6.5%]; p = 0.015), overall work impairment (mean [SE] 59.4% [5.6%] vs. 45.0% [4.4%]; p < 0.001), and activity impairment (mean [SE] 56.8% [1.0%] vs. 44.4% [0.9%]; p < 0.001) were significantly higher in the ≥2 TFs versus preventive-naive group. Emergency department visits (preventive-naive, p = 0.006; 0-1 TF, p = 0.008) and hospitalizations (p < 0.001 both) in the past 6 months were significantly higher in the ≥2 TFs group. Direct and indirect costs were significantly higher in the ≥2 TFs (mean [SE] $24,026 [3460]; $22,074 [20]) versus 0-1 TF ($10,897 [1636]; $17,965 [17]) and preventive-naive ($11,497 [1715]; $17,167 [17]) groups (p < 0.001 for all). Results were similar in the low-frequency EM group. In this NHWS analysis, individuals with more prior preventive TFs experienced significantly higher humanistic and economic burden regardless of HF.

Improvement in predominant back pain following minimally invasive decompression for spinal stenosis.

The objective of this study was to assess the outcomes of patients with predominant back pain (pBP) undergoing minimally invasive decompression surgery compared with patients with nonpredominant back pain (npBP). This was a retrospective cohort study. Patients were divided into two groups based on the presenting complaint: 1) pBP, defined as visual analog scale (VAS) back pain score > VAS leg pain score; and 2) npBP. Changes in patient-reported outcome measures (PROMs) were compared at the early (< 6 months) and late (≥ 6 months) postoperative time points. Outcomes measures were: 1) PROMs (Oswestry Disability Index [ODI], VAS back and leg pain scores, 12-Item Short-Form Health Survey Physical Component Score [SF-12 PCS], and Patient-Reported Outcomes Measurement Information System Physical Function [PROMIS PF]), and 2) minimal clinically important difference (MCID) achievement rate and time. For the late MCID achievement point, a second analysis was conducted restricting VAS back and leg pain scores only to patients with preoperative scores ≥ 5. Three hundred ninety patients were included (126 with pBP and 264 with npBP). There were no differences in patient demographics and operated levels. There were no differences in preoperative ODI, SF-12 PCS, and PROMIS PF scores. The pBP cohort had a significantly greater preoperative VAS back pain score than the npBP cohort, whereas the npBP cohort had a significantly greater preoperative VAS leg pain score than the pBP cohort. There were no differences in the absolute values or changes in ODI, VAS back pain, SF-12 PCS, and PROMIS PF scores at any time point. There was a significant difference in the early VAS leg pain scores (greater in npBP) that disappeared by the late postoperative time point. There was no difference in the MCID achievement rate in the ODI, SF-12 PCS, or PROMIS PF scores. By the late postoperative time point, 51.2% and 55.3% achieved an MCID on the ODI, 58.1% and 62.7% on the SF-12 PCS, 60% and 67.6% on the PROMIS PF, 81.1% and 73.2% on VAS back pain scores for those with preoperative scores ≥ 5, and 72% and 83.6% on VAS leg pain scores for those with preoperative scores ≥ 5 for the pBP and npBP cohorts, respectively. Additionally, there were no differences in time to MCID achievement for any PROMs. The pBP and npBP cohorts showed similar improvement in PROMs and MCID achievement rates. This result shows that minimally invasive laminectomy is equally effective for patients presenting with pBP or npBP.

A single relapse induces worsening of disability and health-related quality of life in patients with neuromyelitis optica spectrum disorder.

Cumulative damage from multiple relapses in neuromyelitis optica spectrum disorder (NMOSD) is associated with poor health-related quality of life (HRQoL) and long-term disability in patients positive for anti-aquaporin 4 antibodies (AQP4+). This study assessed the effect of an individual relapse on HRQoL and disability outcomes in AQP4+ NMOSD. Post hoc analyses of data pooled from the PREVENT study and its open-label extension, which evaluated the efficacy and safety of eculizumab in AQP4+ NMOSD, examined the effect of a single relapse on 3 disability and 4 HRQoL outcome measures. Assuming the effect of 1 relapse extends to multiple relapses, an extrapolation was done to assess the effect of 2 relapses on these outcomes. In 27 patients (placebo: n = 20; eculizumab: n = 7) experiencing an independently adjudicated relapse, 1 relapse led to significantly worse disability (modified Rankin Scale and Expanded Disability Status Scale [EDSS]) and HRQoL (36-item Short-Form Health Survey mental and physical component summaries; European Quality of Life 5-Dimension questionnaire 3-Level visual analogue scale and utility index) scores. In 4 of 7 outcomes, clinically meaningful worsening was more likely for relapsing versus non-relapsing patients (n = 116). Extrapolating the effect of 2 relapses predicted that clinically meaningful worsening was more likely in 6 out of 7 outcomes, including EDSS, for patients experiencing multiple relapses versus patients experiencing no relapses. Findings from these clinical trial data demonstrate that a single NMOSD relapse can worsen disability and HRQoL, underscoring the role of relapse prevention in improving long-term outcomes in patients with AQP4+ NMOSD.

Circulating cold-inducible RNA-binding protein levels in microscopic polyangiitis and granulomatosis with polyangiitis : Correlation with disease activity.

This study investigated whether circulating cold-inducible RNA-binding protein (CIRP) could be abiomarker to reflect the current activity, function, and damage status in patients with microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA). This study selected 39MPA and 26GPA patients. Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)-specific indices include the Birmingham Vasculitis Activity Index (BVAS), five-factor score (FFS), the Korean version of the Short-Form 36-Item Health Survey (SF-36) physical component summary (PCS) and mental component summary (MCS), and the vasculitis damage index (VDI). The highest tertile of BVAS was defined as high activity of AAV. The median age of the study subjects was 65.0years and 53.8% were women. The median BVAS, FFS, SF-36 PCS, MCS, and VDI scores were 12.0, 2.0, 47.5, 50.3, and3.0, respectively. The median circulating CIRP level was 6.4 ng/mL. Among the four AAV-specific indices, circulating CIRP was significantly correlated with BVAS (r = 0.256). Using the receiver operator characteristic curve, the cut-off of circulating CIRP for high activity of AAV was 6.16 ng/mL. High activity of AAV was identified more frequently in patients with circulating CIRP ≥ 6.16 ng/mL than in those with circulating CIRP < 6.16 ng/mL (48.6% vs. 21.4%). In addition, patients with circulating CIRP ≥ 6.16 ng/mL exhibited asignificantly higher risk for high activity of AAV than those with circulating CIRP < 6.16 ng/mL (relative risk 3.474). This study suggests the clinical potential of circulating CIRP as abiomarker for reflecting the current BVAS and predicting high activity of AAV in patients with MPA and GPA.

P434 Upadacitinib improved fatigue and health-related quality of life in patients with moderately to severely active Crohn’s disease: Results from induction and maintenance phase 3 trials

Abstract Background Upadacitinib (UPA) demonstrated efficacy and safety in the phase 3 U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849) induction, and U-ENDURE (NCT03345823) maintenance trials in patients (pts) with moderately to severely active Crohn’s disease (CD). We evaluated the impact of UPA on health-related quality of life (QoL) in pts with CD. Methods Clinical responders to UPA 45 mg (UPA45) in U-EXCEED and U-EXCEL induction trials were re-randomised at Week 12 (1:1:1) to UPA 15 mg (UPA15), UPA 30 mg (UPA30), or placebo (PBO) for 52 weeks of maintenance treatment in U-ENDURE; data from these induction and maintenance trials were included in this analysis. Endpoints included the percentage of pts who achieved an Inflammatory Bowel Disease Questionnaire (IBDQ) response (≥16 points), IBDQ remission (≥170 points), a meaningful within-person change (MWPC) from baseline of ≥9 points on the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F), and of ≥4.1 and ≥3.9 points on the 36-item Short-Form Health Survey (SF-36) physical (PCS) and mental (MCS) component summary scores, respectively, at Weeks 4/12 of induction and Week 52 of maintenance. Adjusted risk differences compared to PBO, 95% confidence intervals, and p-values were calculated based on the Cochran-Mantel-Haenszel test. Results In U-EXCEED (n=324 UPA; 171 PBO) and U-EXCEL (n=350 UPA; 176 PBO), a greater proportion of UPA45- vs PBO-treated pts had an IBDQ response at Weeks 4 (U-EXCEED: 71.6% vs 47.6%; U-EXCEL: 71.0% vs 50.2%; p≤0.001) and 12 (U-EXCEED: 63.9% vs 44.4%; U-EXCEL: 68.4% vs 46.5%; p≤0.001; Figure 1). In UPA- vs PBO-treated pts, a greater proportion achieved IBDQ remission at Weeks 4 (U-EXCEED: 41.4% vs 22.4%; U-EXCEL: 44.2% vs 23.7%; p≤0.001) and 12 (all p≤0.001; Figure 1). At Week 12, a significantly greater proportion of UPA-treated pts vs PBO demonstrated a MWPC in FACIT-F, and SF-36 PCS and MCS from baseline (p≤0.001; Figure 1). Similar results for UPA45 vs PBO were achieved as early as Week 4 in FACIT-F (U-EXCEED: 42.3% vs 20.0%; U-EXCEL: 42.0% vs 27.0%), SF-36 PCS (U-EXCEED: 56.6% vs 37.2%; U-EXCEL: 53.0% vs 37.5%; p≤0.001) and MCS (p≤0.05). In the maintenance study U-ENDURE (n=168 UPA30; 169 UPA15; 165 PBO), a greater proportion of pts receiving UPA15 and UPA30 vs PBO achieved an IBDQ response (39.1%, 53.5% vs 20.4%), IBDQ remission (36.1%, 45.2% vs 13.5%), and a meaningful improvement from baseline in FACIT-F, SF-36 PCS and MCS through 52 weeks (p≤0.01; Figure 2). Conclusion In pts with moderately to severely active CD, UPA treatment significantly improved fatigue, disease-specific and generic QoL, compared with PBO, as early as Week 4 of induction. The effects were sustained through 52 weeks of maintenance treatment.

Improvement following minimally invasive transforaminal lumbar interbody fusion in patients aged 70 years or older compared with younger age groups

The goal of this study was to assess the outcomes of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) in patients ≥ 70 years old and compare them to younger age groups. This was a retrospective study of data that were collected prospectively. Patients who underwent primary single-level MI-TLIF were included and divided into 3 groups: age < 60, 60-69, and ≥ 70 years. The outcome measures were as follows: 1) patient-reported outcome measures (PROMs) (i.e., visual analog scale [VAS] for back and leg pain, Oswestry Disability Index [ODI], 12-Item Short-Form Health Survey Physical Component Summary [SF-12 PCS]); 2) minimum clinically important difference (MCID) achievement; 3) return to activities; 4) opioid discontinuation; 5) fusion rates; and 6) complications/reoperations. A total of 147 patients (age < 60 years, 62; 60-69 years, 47; ≥ 70 years, 38) were included. All the groups showed significant improvements in all PROMs at the early (< 6 months) and late (≥ 6 months) time points and there was no significant difference between the groups. Although MCID achievement rates for VAS leg and ODI were similar, they were lower in the ≥ 70-year-old patient group for VAS back and SF-12 PCS. Although the time to MCID achievement for ODI and SF-12 PCS was similar, it was greater in the ≥ 70-year-old patient group for VAS back and leg. There was no significant difference between the groups in terms of return to activities, opioid discontinuation, fusion rates, and complication/reoperation rates. Although patients > 70 years of age may be less likely and/or take longer to achieve MCID compared to their younger counterparts, they show an overall significant improvement in PROMs, a similar likelihood of returning to activities and discontinuing opioids, and comparable fusion and complication/reoperation rates following MI-TLIF.

Birmingham vasculitis activity score and the short form 36-item health survey predict current depressive disorders in patients with antineutrophil cytoplasmic antibody-associated vasculitis during the SARS-CoV-2 pandemic.

IntroductionThis study compared the frequency and severity of depressive disorders in patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV) before and during the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) pandemic using the Korean version of the Center for Epidemiologic Studies Depression Scale-Revised (K-CESD-R) and the Korean version of the Profile of Mood States (K-POMS) depression, and further determined predictors of current depressive disorders in the patients during the pandemic.MethodsOf the 61 patients with AAV who participated before the pandemic, 8 patients were transferred to other hospitals, 3 patients died, and 2 patients refused to participate in this study. Finally, 48 patients participated in this study. Depression disorders were defined as K‑CESD-R ≥ 16.ResultsWhen comparing the patterns of mental health between patients with AAV before and during the pandemic, no change in K‑CESD‑R or K‑POMS subscale scores was observed. Among AAV-related indices, regardless of the pandemic, the short-form 36-item Health Survey (SF-36) mental component score (MCS) and physical component score (PCS) were significantly correlated with K‑CESD‑R and could predict current depressive disorders. When the cut-off of Birmingham vasculitis activity score (BVAS) for depressive disorders was obtained by the receiver operator characteristic curve, it significantly predicted current depressive disorders in patients with AAV during the pandemic, unlike those before the pandemic.ConclusionWe verified that SF-36 MCS and PCS could predict current depressive disorders, regardless of the pandemic, and furthermore, we demonstrated for the first time that BVAS was a predictor of current depressive disorders in patients with AAV during the pandemic unlike those before the pandemic.Supplementary InformationThe online version of this article (10.1007/s00393-022-01233-1) includes Figure S1 and Table S1.

Supramalleolar Osteotomy vs Arthrodesis for the Treatment of Takakura 3B Ankle Osteoarthritis.

To compare the clinical/functional outcomes of supramalleolar osteotomy (SMOT) and ankle arthrodesis (AA) for the treatment of modified Takakura stage 3B ankle osteoarthritis. Outcomes of 28 SMOT patients and 30 AA patients were reviewed at an average of 50 and 51 months, respectively. The baseline characteristics of the 2 groups were similar. The preoperative tibial articular surface angle and talar tilt angle in the SMOT group were 82.6 and 10 degrees and in the AA group, 83.9 and 9.1 degrees, respectively. The American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot score, visual analog scale (VAS) score, 12-item Short-Form Health Survey (SF-12) mental component summary (MCS) and physical component summary (PCS) scores, range of motion (ROM), radiologic parameters, and complications were compared. The AOFAS, VAS, and SF-12 MCS and PCS scores improved significantly postoperatively in both groups (P < .001). The VAS and SF-12 PCS scores indicate marginally better improvement in the AA group (P < .05). The patient satisfaction value (P = .028) and the possibility of repeated surgery value (P = .012) were also significantly higher in the AA group. The early (P = .905) and late (P = .181) complications did not significantly differ between the 2 groups. The reoperation rate was significantly higher in the SMOT group (P = .038). Both SMOT and AA showed improvements in function, pain, alignment, and quality of life after surgery. Patients in the AA group reported better pain relief, had a lower reoperation rate, and better hindfoot alignment during a short- to mid-term follow-up time. Level III, retrospective comparative study.

Differences in Clinical and Functional Outcomes Between Osteochondral Allograft Transplantation and Autologous Chondrocyte Implantation for the Treatment of Focal Articular Cartilage Defects.

Background:Articular cartilage pathology can result from a spectrum of origins, including trauma, osteochondritis dissecans, avascular necrosis, or degenerative joint disease.Purpose:To compare the differences in clinical and patient-reported outcomes after autologous chondrocyte implantation (ACI) versus osteochondral allograft transplantation (OCA) in patients with focal articular cartilage defects without underlying bone loss.Study Design:Cohort study; Level of evidence, 3.Methods:A retrospective review identified patients who underwent ACI or OCA between 2008 and 2016 for isolated grades 3 and 4 articular cartilage defects without underlying bone loss. Outcome measures included the Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), International Knee Documentation Committee (IKDC) evaluation, and 12-Item Short Form Health Survey–Physical Component (SF-12-P) scores. Defect location, size, complications, and rate of subsequent surgery were determined.Results:Overall, 148 patients were included: 82 (55%) underwent ACI and 66 (45%) underwent OCA. The mean age at the time of surgery was 31.2 years within the ACI cohort and 37.7 years within the OCA cohort (P < .001); the mean follow-up for both cohorts was 6.7 years (P = .902). Within the ACI group, 28 (34%) patients had multifocal defects, 21 (26%) had defects confined to the femoral condyles, and 33 (40%) had defects in the patellofemoral region. Within the OCA group, 23 (35%) patients had multifocal defects, 30 (46%) had confined femoral condyle lesions, and 13 (20%) had patellofemoral defects. When comparing by lesion location, there were no significant differences in KOOS JR, and IKDC scores between the ACI and OCA cohorts (P < .05). There was, however, a significant difference for SF-12-P scores for FDD trochlear lesions. In both cohorts, traumatic patellofemoral pathology demonstrated lower patient-reported outcomes and higher failure rates than degenerative lesions. The overall rate of failure, defined as graft failure with revision surgery and/or conversion to arthroplasty, was significantly greater in the OCA group (21% vs 4%; P = .002).Conclusion:Study results indicated that ACI provides similar outcomes to OCA with or without concomitant procedures for the treatment of symptomatic articular cartilage defects in all lesion locations and may have a lower revision rate for multifocal and condylar lesions.

Serum progranulin as a predictive marker for high activity of antineutrophil cytoplasmic antibody-associated vasculitis.

BackgroundThis study investigated whether serum progranulin could act as a predictive marker for high disease activity of antineutrophil cytoplasmic antibody (ANCA)‐associated vasculitis (AAV).MethodsFifty‐eight AAV patients were included in this study. Clinical and laboratory data were obtained at blood collection. The Short‐Form 36‐Item Health Survey Physical and Mental Component Summaries (SF‐36 PCS and SF‐36 MCS), Birmingham Vasculitis activity score (BVAS), Five‐Factor Score (FFS), and Vasculitis Damage Index (VDI) were assessed as AAV‐specific indices. Whole blood was collected and serum samples were isolated and stored at −80°C. Serum progranulin concentration was quantified by ELISA kits.ResultsThe median age of patients was 63.0 years (19 men). The median BVAS was 11.0, and the median serum progranulin level was 49.0 ng/ml. Serum progranulin was significantly correlated with BVAS, FFS, erythrocyte sedimentation rate, C‐reactive protein level, SF‐36 PCS, haemoglobin, and serum albumin. Severe AAV was arbitrarily defined as the highest tertile of BVAS (BVAS ≥16). When the cut‐offs of serum progranulin were set as 55.16 ng/ml and 43.01 ng/ml for severe AAV, AAV patients with serum progranulin ≥55.16 and 43.01 ng/ml had significantly higher risks of severe AAV than those without (relative risk (RR) 4.167 and 4.524, respectively).ConclusionsProgranulin might play an anti‐inflammatory role in AAV pathogenesis and serum progranulin could be used as a predictive marker for high activity of AAV.

Third-Generation Minimally Invasive Chevron-Akin Osteotomy for Hallux Valgus Produces Similar Clinical and Radiological Outcomes as Scarf-Akin Osteotomy at 2 Years: A Matched Cohort Study.

The minimally invasive chevron-Akin (MICA) osteotomy is an increasingly popular technique for the correction of hallux valgus. However, there is a paucity of literature comparing it with traditional open techniques. The purpose of this study was to compare the clinical and radiological outcomes of the MICA osteotomy using a new-generation MICA screw and scarf-Akin osteotomy for hallux valgus correction. Thirty cases of MICA osteotomy were propensity score matched 1:1 with a control group of 30 scarf-Akin osteotomy cases. The groups were matched for age, sex, body mass index, preoperative visual analog scale (VAS) score, American Orthopaedic Foot & Ankle Society (AOFAS) metatarsophalangeal-interphalangeal (MTP-IP) score, 36-Item Short-Form Health Survey (SF-36) physical component score (PCS) and mental component score (MCS), preoperative hallux valgus angle (HVA) and intermetatarsal angle (IMA), and concomitant procedures. Outcomes were compared at 6 and 24 months postoperatively. Early postoperative VAS scores were also compared. Both groups demonstrated significant improvements in VAS score, AOFAS score, and SF-36 PCS and MCS at 6 and 24 months postoperatively. For the MICA group, HVA improved from 23.5 to 7.7 degrees, and IMA improved from 13.5 to 7.5 degrees. For the scarf-Akin osteotomy group, HVA improved from 23.7 to 9.3 degrees, and IMA improved from 13.6 to 7.8 degrees. The first 24-hour postoperative VAS score was significantly lower in the MICA group compared with the scarf-Akin group (2.0 ± 2.0 vs 3.4 ± 2.6, P = .029). However, there was no significant difference in clinical or radiological outcomes between the groups at 6 and 24 months. The MICA procedure with the new-generation MICA screw is an attractive option for the correction of hallux valgus, yielding similar midterm radiological and clinical outcomes compared with the well-established scarf-Akin osteotomy. The first 24-hour postoperative VAS score in the MICA group was also statistically lower, although its clinical significance remains to be determined. Level III, retrospective comparative study.

Real-World Outcomes in Historically Underserved Patients with Chronic HepatitisC Infection Treated with Glecaprevir/Pibrentasvir.

IntroductionGlecaprevir/pibrentasvir is approved for treating chronic hepatitis C virus (HCV) genotypes (GT) 1–6. We evaluated real-world effectiveness, safety, and patient-reported outcomes of glecaprevir/pibrentasvir in underserved patient populations, focusing on persons who use drugs infected with HCV.MethodsData were pooled from nine countries (13 November 2017–31 January 2020). Patients had HCV GT1–6, with or without compensated cirrhosis, with or without prior HCV treatment and received glecaprevir/pibrentasvir consistent with local label at their physician’s discretion. Patients with prior direct-acting antiviral exposure were excluded from efficacy and quality-of-life analyses. The percentage of patients achieving sustained virologic response at post-treatment week 12 (SVR12) was assessed. Mean changes from baseline to SVR12 visit in 36-Item Short-Form Health Survey mental and physical component summary scores were reported. Safety was assessed in patients receiving at least one dose of glecaprevir/pibrentasvir.ResultsOf 2036 patients, 1701 (83.5%) received 8-week glecaprevir/pibrentasvir. In 1684 patients with sufficient follow-up, SVR12 rates were 98.0% (1651/1684) overall, 98.1% (1432/1459) in 8-week treated patients, 97.0% (519/535) in persons who use drugs, and greater than 95% across subgroups. Mean changes from baseline in mental and physical component summary scores were 3.7 and 2.4, respectively. One glecaprevir/pibrentasvir-related serious adverse event was reported; six glecaprevir/pibrentasvir-related adverse events led to discontinuation.ConclusionsGlecaprevir/pibrentasvir was highly effective, well tolerated, and improved quality of life in HCV-infected persons who use drugs and other underserved patients.Trial RegistrationThese multinational post-marketing observational studies are registered with ClinicalTrials.gov, number NCT03303599.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40121-021-00455-1.

The differential effect of cervical kyphosis correction surgery on global sagittal alignment and health-related quality of life according to head- and trunk-balanced subtype.

No reports have investigated how cervical reconstructive surgery affects global sagittal alignment (GSA), including the lower extremities, and health-related quality of life (HRQOL). The study was aimed at elucidating the effects of cervical reconstruction on GSA and HRQOL. Twenty-three patients who underwent reconstructive surgery for cervical kyphosis were divided into a head-balanced group (n = 13) and a trunk-balanced group (n = 10) according to the values of the C7 plumb line, T1 slope (T1S), and pelvic incidence minus lumbar lordosis (PI-LL). Head-balanced patients are those with a negative C7 sagittal vertical axis (SVA), a larger LL than PI, and a low T1S. Trunk-balanced patients are those with a positive SVAC7, a normal PI-LL, and a normal to high T1S. Various sagittal Cobb angles, SVA, and lower-extremity alignment parameters were measured before and after surgery using whole-body stereoradiography. Cervical malalignment was corrected to achieve cervical sagittal balance and occiput-trunk (OT) concordance (center of gravity [COG]-C7 SVA < 30 mm). Significant changes in the upper cervical spine and thoracolumbar spine were observed in the head-balanced group, but no significant change in lumbopelvic alignment was observed in the trunk-balanced group. Lower-extremity alignment did not change substantially in either group. HRQOL scores improved significantly after surgery in both groups. SVACOG-C7 and SVAC2-7 were negatively and positively correlated with the 36-Item Short-Form Health Survey physical component score and Neck Disability Index, respectively. The visual analog scale for back pain, Oswestry Disability Index, and PI-LL mismatch improved significantly in the head-balanced group after cervical reconstruction surgery. Patients with cervical kyphosis exhibited compensatory changes in the upper cervical spine and thoracolumbar spine, instead of in the lower extremities. These compensatory mechanisms resolved reciprocally in a different fashion in the head- and trunk-balanced groups. HRQOL scores improved significantly with GSA restoration and OT concordance following cervical reconstruction.