Survey Physical Component Summary Scores Research Articles

Clinical Outcomes of a Novel Hybrid Transtibial Technique for Femoral Tunnel Drilling in Anterior Cruciate Ligament Reconstruction: A Large Single-Center Case Series With a Minimum 2-Year Follow-up

Background: A novel hybrid transtibial (HTT) approach to femoral tunnel drilling in anterior cruciate ligament reconstruction (ACLR) has been developed that circumvents the need for knee hyperflexion and orients the graft in the most anatomic position without sacrificing the tunnel length or aperture. Hypothesis: Patients who underwent ACLR utilizing the HTT technique would achieve excellent patient-reported outcome scores and experience low rates of graft failure and reoperations. Study Design: Case series; Level of evidence, 4. Methods: Patients who underwent primary ACLR at a single institution between 2005 and 2020 were retrospectively reviewed. Patients treated with the HTT, anteromedial portal (AMP), and transtibial (TT) approaches were matched based on age, sex, and body mass index ±3 kg/m2. Demographic and surgical data as well as femoral tunnel angle measurements on anteroposterior and lateral radiographs were collected for the 3 groups. However, clinical outcomes were only reported for the HTT group because of concerns of graft heterogeneity. Results: A total of 170 patients (median age, 26.5 years [interquartile range (IQR), 18.0-35.0 years]) who underwent ACLR using the HTT approach were included. The median coronal- and sagittal-plane femoral tunnel angles were 47° (IQR, 42°-53°) and 40° (IQR, 34°-46°), respectively. The sagittal-plane femoral tunnel angles in the HTT group were significantly more horizontal compared with those in the TT group ( P < .0001), whereas the coronal-plane femoral tunnel angles in the HTT group were found to be significantly more vertical compared with those in the AMP group ( P = .001) and more horizontal compared with those in the TT group ( P < .0001). The graft failure and reoperation rates in the HTT group at a minimum 2-year follow-up were 1.8% (3/170) and 4.7% (8/170), respectively. The complication rate was 6.5% (11/170), with the most common complication being subjective stiffness in 7 patients. The median Lysholm score was 89.5 (IQR, 79.0-98.0); the median International Knee Documentation Committee score was 83.9 (IQR, 65.5-90.8); and the median Veterans RAND 12-Item Health Survey physical and mental component summary scores were 55.0 (IQR, 52.6-55.9) and 56.2 (IQR, 49.1-59.3), respectively. Conclusion: ACLR using the HTT technique was associated with low graft retear and revision surgery rates and good patient-reported outcome scores at medium-term follow-up and demonstrated femoral tunnel obliquity on postoperative radiographs that correlated with optimal parameters previously reported in cadaveric and biomechanical studies.

Short-term Comparison of Survivorship and Functional Outcomes for Metaphyseal Cones with Short and Long Stems in Revision Total Knee Arthroplasty.

Printed porous titanium metaphyseal cones have become a mainstay for managing bone loss in revision total knee arthroplasty (rTKA). A short or long stem is routinely used when implanting a cone to augment fixation and offload stresses. This retrospective analysis compared the short-term survivorships and functional outcomes for use of a short or long stem with a metaphyseal cone.A total of 179 cases using metaphyseal cones and stems with median follow-up of 1.95 years (interquartile range, 1.00-2.14) were compared based on stem type. There were 55 cases with long stem(s) and 124 cases with short stem(s). Cases with both long and short stems were excluded. Demographics, Kaplan-Meier survivorships, and preoperative and 1-year postoperative patient-reported outcome measures (PROMs; 2011 Knee Society Score [KSS] objective knee score, function, and satisfaction scores; EuroQol five-dimension scale; and Short Form Survey Physical Component Summary and Mental Component Summary scores) were compared using t-tests with a significance level of α = 0.05. There were no significant differences in body mass index (mean ± standard deviation) or sex (men [%]) between the short and long stem cohorts (32.3 ± 5.3, 36.3% and 31.5 ± 5.5, 38.2%, respectively; p > 0.05). Patients who had short stems were younger (65.9 ± 8.8 vs. 69.0 ± 9.4, p = 0.0323).Revision-free survivorship for the femoral or tibial component was 100% for long stems and 98.2% for short stems at 1 and 2 years, respectively (log-rank p = 0.6330). The two revisions in the short group were for infection, thus the survivorship for aseptic loosening was 100% at 2 years for both cohorts. There were no significant differences in preoperative or postoperative PROMs.This study demonstrated that highly porous printed metaphyseal cones provided rTKA with excellent early survivorship and similar PROMs whether a short or long stem was used. Additional studies will be needed to discern longer term differences.

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.

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.

Do Contemporary Cancer Survivors Experience Better Quality of Life? Evaluating a Decade of SEER Medicare Health Outcomes Survey Data.

A cancer diagnosis may have deleterious effects on health-related quality of life (HRQOL) as adults age. This study examined differences in HRQOL between cancer and matched noncancer Medicare beneficiaries over 65, within and across two time periods. We used novel matching methods on data from the Surveillance, Epidemiology and End Results (SEER)-Medicare Health Outcomes Survey (MHOS) data resource. We matched SEER-MHOS respondents with cancer from a recent period (2015-2019) to respondents with cancer from an earlier period (2008-2012). We then matched these two cohorts, without replacement, to contemporary cohorts without cancer diagnoses. We estimated Veteran's RAND 12-Item Short Form Survey Physical Component Summary (PCS) and Mental Component Summary (MCS) scores for all cohorts. Our analysis found significantly higher mean MCS scores in the recent period for those with cancer relative to the recent noncancer control group. Breast and lung cancer presented positive and statistically significant trends. We found statistically insignificant differences in PCS scores between the two time periods. No cancer sites had different PCS scores over time compared with the comparison group. Mental health for those with cancer improved more between 2008 and 2019 than a matched noncancer comparison group. Physical health remained stable across time. These findings highlight the importance of including a matched noncancer group when evaluating HRQOL outcomes. SEER-MHOS respondents with cancer report stable PCS scores across 15 years of data and higher MCS scores relative to noncancer controls.

Minimally invasive sacroiliac joint fusion using triangular titanium implants versus nonsurgical management for sacroiliac joint dysfunction: a systematic review and meta-analysis.

Minimally invasive sacroiliac joint (MISIJ) fusion is a surgical option to relieve SIJ pain. The aim of this systematic review and meta-analysis was to compare MISIJ fusion with triangular titanium implants (TTI) to nonoperative management of SIJ dysfunction. We searched MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials. We included prospective clinical trials that compared MISIJ fusion to nonoperative management in individuals with chronic low back pain attributed to SIJ dysfunction. We evaluated pain on visual analogue scale, Oswestry Disability Index (ODI) score, health-related quality of life (HRQoL) using the 36-Item Short Form Health Survey (SF-36) physical component (PCS) and mental component summary (MCS) scores, patient satisfaction, and adverse events. A total of 8 articles representing 3 trials that enrolled 423 participants were deemed eligible. There was a significant reduction in pain score with MISIJ fusion compared with nonoperative management (standardized mean difference [SMD] -1.71, 95% confidence interval [CI] -2.03 to -1.39). Similarly, ODI scores (SMD -1.03, 95% CI -1.24 to -0.81), SF-36 PCS scores (SMD 1.01, 95% CI 0.83 to 1.19), SF-36 MCS scores (SMD 0.72, 95% CI 0.54 to 0.9), and patient satisfaction (odds ratio 6.87, 95% CI 3.73 to 12.64) were significantly improved with MISIJ fusion. No significant difference was found between the 2 groups with respect to adverse events (SMD -0.03, 95% CI -0.28 to 0.23). Our analysis showed that MISIJ fusion with TTI shows a clinically important and statistically significant improvement in pain, disability score, HRQoL, and patient satisfaction with a similar adverse event profile to nonoperative management in patients with chronic low back pain attributed to SIJ dysfunction.

Cannabis for medical use versus opioids for chronic non-cancer pain: a systematic review and network meta-analysis of randomised clinical trials

ObjectiveThe objective of this study is to evaluate the comparative benefits and harms of opioids and cannabis for medical use for chronic non-cancer pain.DesignSystematic review and network meta-analysis.Data sourcesEMBASE, MEDLINE,...

Sustained Efficacy, Safety, and Improved Quality of Life in Adult and Pediatric Patients with Transfusion-Dependent β-Thalassemia up to 9 Years Post Treatment with Betibeglogene Autotemcel (Beti-cel)

Introduction: Beti-cel gene therapy addresses the underlying cause of transfusion-dependent β-thalassemia (TDT) by adding functional copies of a modified β-globin gene to autologous CD34+ hematopoietic stem and progenitor cells (HSPCs) via a third-generation, self-inactivating lentiviral vector (LVV), BB305, which produces functional adult hemoglobin (Hb), HbA T87Q, in red blood cells (RBCs). Here, we report efficacy, safety, and quality of life (QOL) data from adult and pediatric patients treated with beti-cel who were followed for up to 9 years after treatment. These outcomes may inform patient selection for real-world treatment with beti-cel. Methods: Patients with TDT who completed either a phase 1/2 (HGB-204 [NCT01745120]; HGB-205 [NCT02151526]) or phase 3 (HGB-207 [NCT02906202]; HGB-212 [NCT03207009]) beti-cel parent study and subsequently participated in the long-term, 13-year follow-up study LTF-303 (NCT02633943) were included in this analysis. Analyses were performed with data collected through January 30, 2023. Efficacy (including transfusion independence [TI], defined as a weighted average Hb ≥9 g/dL without packed RBC transfusions for ≥12 months) and safety are reported through last follow-up. QOL data are reported for studies HGB-204, HGB-207, and HGB-212 through month 36. Statistical analyses were conducted to examine key outcomes in subgroups based on patient age at enrollment (pediatric: &amp;lt;18 years; adult: ≥18 years). Results:As of January 30, 2023, 63 patients (median [range] age: 17 [4-35] years) had received beti-cel in a phase 1/2 or 3 study and enrolled in LTF-303, with a median (range) follow-up of 60.1 (23.8-109.5) months. Phase 3 studies used the commercial drug product manufacturing process. Ninety percent (37/41) of phase 3 patients achieved and maintained TI through last follow-up (up to 6 years; Table 1). TI rates by study, genotype, and age for phase 3 patients are also presented in Table 1. In phase 1/2 studies that used an older drug manufacturing process, 68.2% (15/22) of patients achieved TI; 14 of these patients sustained TI through last follow-up (up to 9 years). One patient no longer meets protocol-defined TI as a result of Hb level &amp;lt;9g/dL at year 6 due to acute health events unrelated to β-thalassemia, which were not attributed to loss of beti-cel treatment effect. Approximately 80% of pediatric and adult patients required only one mobilization cycle to achieve the drug product dose. The median percentage of drug product cells transduced with the BB305 LVV was comparable between adult and pediatric populations (78% and 80%, respectively), as were the month 6 median peripheral blood vector copy number (1.4 c/dg and 1.1 c/dg) and HbA T87Q (9.4 g/dL and 8.3 g/dL). Adult patients reported improvements in QOL up to month 36 as assessed by the Short Form-36 Health Survey Questionnaire mental and physical component summary scores, Functional Assessment of Cancer Therapy, and EuroQol ( Table 2). Pediatric Quality of Life Inventory scores will be reported at the time of presentation. Overall, 19% (12/63) of patients experienced ≥1 beti-cel-related adverse event (AE); the most common beti-cel-related AEs (occurring in ≥3 patients) were abdominal pain (experienced in 5/63 [7.9%] patients) and thrombocytopenia (3/63 [4.8%] patients). Five patients experienced serious veno-occlusive liver disease; all 5 received defibrotide and recovered. No malignancies, insertional oncogenesis, or vector-derived replication-competent lentivirus were reported. Age subgroup safety analysis as of last follow-up will be reported in the final presentation. Conclusion: Beti-cel is a potentially curative gene therapy for patients with TDT across ages and genotypes through achievement of TI and normal or near-normal Hb. These data will inform real-world beti-cel treatment decisions for patients with TDT and providers.

Standardizing Physical Activity Monitoring in Patients With Degenerative Lumbar Disorders.

Degenerative thoracolumbar disorders (DTDs) typically cause pain and functional impairment. However, little is known regarding the DTD impact on patient's real-life physical activity. The objective of this study is to validate a wearable measure of physical activity monitoring in patients with DTD and to create gender- and sex-specific performance thresholds that are standardized to the mean of a control population. A commercially available smartwatch (Apple Watch) was used to monitor preoperative physical activity in patients undergoing surgery for DTD. Mean preoperative physical activity 2 weeks before the scheduled surgery was expressed as raw step count. Standardized z-scores were referenced to age- and sex-specific values of a control population from a large public database. Step counts were assessed for convergent validity with established patient-reported outcome measures, and impairment in activity was stratified into performance groups based on z-score cutoff values. Sixty-five patients (62% female) with a mean (±SD) age of 63.8 (±12.8) years had a mean preoperative daily step count of 5556 (±3978). Physical activity showed significant correlation with patient-reported outcome measures, including Oswestry disability index (r = -0.26, 95% CI: -0.47-0.01), 36-Item Short Form Survey Physical Component Summary score (r = 0.30, 95% CI: 0.06-0.51), and Patient-Reported Outcomes Measurement Information System Physical Function (r = 0.49, 95% CI: 0.27-0.65). "No," "Mild," "moderate," and "severe impairment" in activity performance were defined as corresponding z-scores of >0, 0 to -0.99, -1 to -1.99, and ≤-2, accounting for 22%, 34%, 40%, and 5% of the study population. Each one-step category increase in activity impairment resulted in increased subjective disability as measured by the Oswestry Disability Index, 36-Item Short Form Survey Physical Component Summary, and Patient-Reported Outcomes Measurement Information System Physical Function (all P -values <.05). We establish the first wearable objective measure of real-life physical activity for patients with DTD, with the first age- and sex-adjusted standard scores to enable clinicians and researchers to set treatment goals and directly compare activity levels between individual patients with DTD and normal controls.

Mid-term and Long-term Outcomes After Total Cervical Disk Arthroplasty Compared With Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

A meta-analysis of randomized controlled trials (RCTs). The aim of this study was to compare mid-term to long-term outcomes of cervical disk arthroplasty (CDA) with those of anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic cervical degenerative disk disease. After ACDF to treat symptomatic cervical degenerative disk disease, the loss of motion at the index level due to fusion may accelerate adjacent-level disk degeneration. CDA was developed to preserve motion and reduce the risk of adjacent segment degeneration. Early-term to mid-term clinical outcomes from RCTs suggest noninferiority of CDA compared with ACDF, but it remains unclear whether CDA yields better mid-term to long-term outcomes than ACDF. Two independent reviewers searched PubMed, Embase, and the Cochrane Library for RCTs with at least 60 months of follow-up. The risk ratio or standardized mean difference (and 95% CIs) were calculated for dichotomous or continuous variables, respectively. Eighteen reports of 14 RCTs published in 2014-2023 were included. The pooled analysis demonstrated that the CDA group had a significantly greater improvement in neurological success and Neck Disability Index than the ACDF group. The ACDF group exhibited a significantly better improvement in the Short Form-36 Health Survey Physical Component Summary than the CDA group. Radiographic adjacent segment degeneration was significantly lower in the CDA group at 60- and 84-month follow-ups; at 120-month follow-up, there was no significant difference between the 2 groups. Although the overall rate of secondary surgical procedures was significantly lower in the CDA group, we did not observe any significant difference at 60-month follow-up between the CDA and ACDF group and appreciated statistically significant lower rates of radiographic adjacent segment degeneration, and symptomatic adjacent-level disease requiring surgery at 84-month and 108- to 120-month follow-up. The rate of adverse events and the neck and arm pain scores in the CDA group were not significantly different from those of the ACDF group. In this meta-analysis of 14 RCTs with 5- to 10-year follow-up data, CDA resulted in significantly better neurological success and Neck Disability Index scores and lower rates of radiographic adjacent segment degeneration, secondary surgical procedures, and symptomatic adjacent-level disease requiring surgery than ACDF. ACDF resulted in improved Short Form-36 Health Survey Physical Component Summary scores. However, the CDA and ACDF groups did not exhibit significant differences in overall changes in neck and arm pain scores or rates of adverse events.

Effect of a Peer Health Coaching Intervention on Clinical Outcomes Among US Veterans With Cardiovascular Risks

Although cardiovascular disease (CVD) is the leading cause of death in the US, CVD risk factors remain suboptimally controlled. To test the effectiveness of a home-visit, peer health coaching intervention to improve health outcomes for veterans with multiple CVD risks. This 2-group, unblinded randomized clinical trial, called Vet-COACH (Veteran Peer Coaches Optimizing and Advancing Cardiac Health), used a novel geographic-based method to recruit a racially diverse population of veterans with low income. These veterans were enrolled at the Seattle or American Lake Veterans Health Affairs primary care clinics in Washington state. Veterans with a diagnosis of hypertension with at least 1 blood pressure reading of 150/90 mm Hg or higher in the past year, and 1 other CVD risk factor (current smoker, overweight or obesity, and/or hyperlipidemia), who resided in Census tracts with the highest prevalence of hypertension were eligible to participate. Participants were randomized to the intervention group (n = 134) or control group (n = 130). An intention-to-treat analysis was performed from May 2017 to October 2021. Participants in the intervention group received peer health coaching for 12 months with mandatory and optional educational materials, an automatic blood pressure monitor, a scale, a pill organizer, and healthy nutrition tools. Participants in the control group received usual care plus educational materials. The primary outcome was a change in systolic blood pressure (SBP) from baseline to 12-month follow-up. Secondary outcomes included change in health-related quality of life (HRQOL; measured using the 12-item Short Form survey's Mental Component Summary and Physical Component Summary scores), Framingham Risk Score, and overall CVD risk and health care use (hospitalizations, emergency department visits, and outpatient visits). The 264 participants who were randomized (mean [SD] age of 60.6 [9.7] years) were predominantly male (229 [87%]) and 73 (28%) were Black individuals and 103 (44%) reported low annual income (<$40 000 per year). Seven peer health coaches were recruited. No difference was found in change in SBP between the intervention and control groups (-3.32 [95% CI, -6.88 to 0.23] mm Hg vs -0.40 [95% CI, -4.20 to 3.39] mm Hg; adjusted difference in differences, -2.05 [95% CI, -7.00 to 2.55] mm Hg; P = .40). Participants in the intervention vs control group reported greater improvements in mental HRQOL scores (2.19 [95% CI, 0.26-4.12] points vs -1.01 [95% CI, -2.91 to 0.88] points; adjusted difference in differences, 3.64 [95% CI, 0.66-6.63] points; P = .02). No difference was found in physical HRQOL scores, Framingham Risk Scores, and overall CVD risk or health care use. This trial found that, although the peer health coaching program did not significantly decrease SBP, participants who received the intervention reported better mental HRQOL compared with the control group. The results suggest that a peer-support model that is integrated into primary care can create opportunities for well-being improvements beyond blood pressure control. ClinicalTrials.gov Identifier: NCT02697422.

Two-Year Clinical and Radiologic Outcomes Following Surgical Treatment of Insertional Achilles Tendinopathy Using a Central Tendon-Splitting Approach.

If conservative treatment of insertional Achilles tendinopathy (IAT) fails, surgery is often considered. Various surgical approaches have been used including the central Achilles tendon splitting approach. This study aimed to report the 2-year clinical and radiologic outcomes after surgical treatment of IAT with a central tendon-splitting approach. Seventy-five cases of IAT treated surgically via the open central tendon-splitting approach were analyzed. Clinical outcomes included the American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot score, visual analog scale (VAS), 36-Item Short Form Health Survey (SF-36) physical (PCS) and mental (MCS) component summary scores, all measured at baseline and 6 and 24 months postoperatively. Radiologic parameters measured included the Fowler-Philip angle (FPA) and parallel pitch lines (PPL). Three patients had clinically significant wound issues but healed completely by 3 weeks. Mean AOFAS score improved from 45.63 preoperatively to 94.71 at 24 months. Mean VAS score improved from 6.73 preoperatively to 0.55, mean SF-36 PCS from 35.98 to 48.74, and mean SF-36 MCS from 53.04 to 55.43 at 24 months. Satisfaction at 2 years was 94.3%. Mean FPA decreased from 62.0 degrees preoperatively to 34.0 degrees postoperatively. PPL was positive in 82.7% (62 of 75) of cases preoperatively, decreasing to 1.3% (1 of 75) postoperatively. Increasing age and higher preoperative VAS and SF-36 MCS scores were significantly associated with improvements in postoperative AOFAS, SF-36 PCS, and MCS scores. Surgical treatment of IAT via the central tendon-splitting approach achieved substantial improvements in all patient-reported outcome measures measured. These excellent clinical outcomes continued to show improvement 2 years postoperatively. Level III, retrospective cohort study.

Deployment-related concussion and long-term health-relatedquality of life among US military personnel.

To examine the relationship between deployment-related concussion and long-term health-related quality of life (HRQoL) among injured US military personnel. The study sample included 810 service members with deployment-related injuries between 2008 and 2012 who responded to a web-based longitudinal health survey. Participants were categorized into three injury groups: concussion with loss of consciousness (LOC; n = 247), concussion without LOC (n = 317), or no concussion (n = 246). HRQoL was measured using the 36-Item Short Form Health Survey physical and mental component summary (PCS and MCS) scores. Current post-traumatic stress disorder (PTSD) and depression symptoms were examined. Multivariable linear regression models assessed the effects of concussion on PCS and MCS scores, while controlling for covariates. A lower PCS score was observed in participants with concussion with LOC (B = - 2.65, p = 0.003) compared with those with no history of concussion. Symptoms of PTSD (PCS: B = - 4.84, p < 0.001; MCS: B = - 10.53, p < 0.001) and depression (PCS: B = - 2.85, p < 0.001; MCS: B = - 10.24, p < 0.001) were the strongest statistically significant predictors of lower HRQoL. Concussion with LOC was significantly associated with lower HRQoL in the physical domain. These findings affirm that concussion management should integrate physical and psychological care to improve long-term HRQoL and warrant a more detailed examination of causal and mediating mechanisms. Future research should continue to incorporate patient-reported outcomes and long-term follow-up of military service members to further define the lifelong impact of deployment-related concussion.

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.

Upper Limb Nerve Transfer Surgery in Patients With Tetraplegia

Cervical spinal cord injury (SCI) causes devastating loss of upper extremity function and independence. Nerve transfers are a promising approach to reanimate upper limbs; however, there remains a paucity of high-quality evidence supporting a clinical benefit for patients with tetraplegia. To evaluate the clinical utility of nerve transfers for reanimation of upper limb function in tetraplegia. In this prospective case series, adults with cervical SCI and upper extremity paralysis whose recovery plateaued were enrolled between September 1, 2015, and January 31, 2019. Data analysis was performed from August 2021 to February 2022. Nerve transfers to reanimate upper extremity motor function with target reinnervation of elbow extension and hand grasp, pinch, and/or release. The primary outcome was motor strength measured by Medical Research Council (MRC) grades 0 to 5. Secondary outcomes included Sollerman Hand Function Test (SHFT); Michigan Hand Outcome Questionnaire (MHQ); Disabilities of Arm, Shoulder, and Hand (DASH); and 36-Item Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary (MCS) scores. Outcomes were assessed up to 48 months postoperatively. Twenty-two patients with tetraplegia (median age, 36 years [range, 18-76 years]; 21 male [95%]) underwent 60 nerve transfers on 35 upper limbs at a median time of 21 months (range, 6-142 months) after SCI. At final follow-up, upper limb motor strength improved significantly: median MRC grades were 3 (IQR, 2.5-4; P = .01) for triceps, with 70% of upper limbs gaining an MRC grade of 3 or higher for elbow extension; 4 (IQR, 2-4; P < .001) for finger extensors, with 79% of hands gaining an MRC grade of 3 or higher for finger extension; and 2 (IQR, 1-3; P < .001) for finger flexors, with 52% of hands gaining an MRC grade of 3 or higher for finger flexion. The secondary outcomes of SHFT, MHQ, DASH, and SF36-PCS scores improved beyond the established minimal clinically important difference. Both early (<12 months) and delayed (≥12 months) nerve transfers after SCI achieved comparable motor outcomes. Continual improvement in motor strength was observed in the finger flexors and extensors across the entire duration of follow-up. In this prospective case series, nerve transfer surgery was associated with improvement of upper limb motor strength and functional independence in patients with tetraplegia. Nerve transfer is a promising intervention feasible in both subacute and chronic SCI.

Comparison of disease activity index for psoriatic arthritis (DAPSA) and minimal disease activity (MDA) targets for patients with psoriatic arthritis: A post hoc analysis of data from phase 3 tofacitinib studies

ObjectiveTo compare achievement of Disease Activity Index in Psoriatic Arthritis (DAPSA) remission (REM)/low disease activity (LDA) with very low disease activity (VLDA)/minimal disease activity (MDA) targets in tofacitinib-treated patients with psoriatic arthritis (PsA). MethodsIn this post hoc analysis, data were pooled from two phase 3 studies (6 months’ [NCT01882439] and 12 months’ [NCT01877668] duration) of patients with PsA receiving tofacitinib 5 or 10 mg twice daily. Cut-offs for DAPSA targets: ≤4 for clinical REM and >4–≤14 for LDA. VLDA and MDA were defined as meeting 7 or ≥5, respectively, of 7 criteria. An ordered logistic regression model was performed to evaluate associations between baseline characteristics and achievement of DAPSA targets as well as VLDA/MDA at month 3. Agreement between achieving DAPSA and VLDA/MDA targets at months 1–6 was assessed via kappa tests. Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) scores (month 6), modified Total Sharp Score (mTSS) and proportion of radiographic non-progressors (mTSS ≤0.5) at month 12 (NCT01877668 only) were compared across DAPSA and VLDA/MDA targets. ResultsIncreased disease activity at baseline was associated with reduced likelihood of achieving DAPSA-REM/DAPSA-LDA or VLDA/MDA at month 3. There was moderate agreement (kappa values 0.41–0.60) between DAPSA-REM and VLDA, and DAPSA-LDA and MDA, from months 1 to 6, although over half of patients achieving DAPSA-REM and over two thirds of patients achieving DAPSA-LDA, respectively, were not captured by VLDA and MDA. Achieving DAPSA-REM/DAPSA-LDA or VLDA/MDA was associated with improved HAQ-DI and SF-36 PCS scores at month 6, and slightly reduced radiographic progression at month 12. ConclusionThis analysis of data from tofacitinib-treated patients with PsA demonstrated moderate agreement between the DAPSA and VLDA/MDA composite instruments. In agreement with previous studies, VLDA and MDA may be more difficult to achieve than DAPSA-REM and DAPSA-LDA, respectively. However, the clinical and prognostic relevance of this finding should be determined. These data support DAPSA and VLDA/MDA as useful tools for evaluating disease activity and treatment response in PsA. ClinicalTrials.govNCT01882439; NCT01877668

Comparison of laparoscopic versus open simple nephrectomy in patients with xanthogranulomatous pyelonephritis: A singlecenter analysis of outcomes and predictors of surgical approaches and complications.

The aim of this study was to compare the outcomes of open simple nephrectomy and laparoscopic simple nephrectomy in patients with xanthogranulomatous pyelonephritis (XGP) in a single-institutional retrospective study and to identify predictive factors of surgical approaches and complications. We retrospectively analyzed the data of 67 consecutive patients with a histopathological diagnosis of XGP who underwent either open simple nephrectomy (ON) or laparoscopic simple nephrectomy (LN) from January 2014 to April 2020. The primary endpoint was the evaluation of perioperative outcomes and complications. Secondary endpoints were to define factors influencing the surgical approach and the likelihood of postoperative complications. Overall, 44 out of 67 patients (65.67%) underwent ON, while 23 (34.33%) underwent LN. Patients in the ON group experienced more postoperative pain according to the visual analogic scale (p = 0.032). Moreover, time to deambulation and time to return to full daily activities, assessed according to the 12-Item Short Form Survey physical and mental component summary scores questionnaires, were significantly shorter in the LN group (p = 0.021, p < 0.001, and p < 0.001, respectively). Of note, there were no significant differences in intraoperative and postoperative complication rates among the groups (p = 0.258 and p = 0.317, respectively). No conversion to open surgery was described. Logistic regression analysis demonstrated that urgency (p = 0.025) was the only predictor associated with a higher risk of intraoperative complications. However, no independent factors associated with postoperative complications or with the surgical approach of choice were found. Based on our results, laparoscopic treatment of XGP represents a feasible alternative to ON, resulting in less postoperative pain and faster recovery. In skilled hands, LN should be considered as the treatment of choice for XGP.

Long-term efficacy and safety of inotersen for hereditary transthyretin amyloidosis: NEURO-TTR open-label extension 3-year update

BackgroundHereditary transthyretin amyloidosis (hATTR/ATTRv) results from the deposition of misfolded transthyretin (TTR) throughout the body, including peripheral nerves. Inotersen, an antisense oligonucleotide inhibitor of hepatic TTR production, demonstrated a favorable efficacy and safety profile in patients with the polyneuropathy associated with hATTR in the NEURO-TTR (NCT01737398) study. We report longer-term efficacy and safety data for inotersen, with a median treatment exposure of 3 years.MethodsPatients who satisfactorily completed NEURO-TTR were enrolled in its open-label extension (OLE) study. Efficacy assessments included the modified Neuropathy Impairment Score + 7 (mNIS + 7), Norfolk Quality of Life–Diabetic Neuropathy (Norfolk QoL-DN) questionnaire total score, and the Short Form 36 (SF-36v2) Health Survey Physical Component Summary score. Safety and tolerability were also assessed. Efficacy is reported for patients living in Europe and North America (this cohort completed the study approximately 9 months before the remaining group of patients outside these regions); safety is reported for the full safety dataset, comprising patients living in Europe, North America, and Latin America/Australasia. This study is registered with ClinicalTrials.gov, identifier NCT02175004.ResultsIn the Europe and North America cohort of the NEURO-TTR study, 113/141 patients (80.1%) completed the study, and 109 patients participated in the OLE study. A total of 70 patients continued to receive inotersen (inotersen–inotersen) and 39 switched from placebo to inotersen (placebo–inotersen). The placebo–inotersen group demonstrated sustained improvement in neurological disease progression as measured by mNIS + 7, compared with predicted worsening based on projection of the NEURO-TTR placebo data (estimated natural history). The inotersen–inotersen group demonstrated sustained benefit, as measured by mNIS + 7, Norfolk QoL-DN, and SF-36v2, compared with estimated natural history as well as compared with the placebo–inotersen group. With a maximum exposure of 6.2 years, inotersen was not associated with any additional safety concerns or increased toxicity in the OLE study. Platelet and renal monitoring were effective in reducing the risk of severe adverse events in the OLE study.ConclusionInotersen treatment for > 3 years slowed progression of the polyneuropathy associated with hATTR, and no new safety signals were observed.

Lifestyle Intervention Strategy to Treat Diabetes in Older Adults: A Randomized Controlled Trial.

Lifestyle intervention is recommended as first-line treatment of diabetes at all ages; however, little is known about the efficacy of lifestyle intervention in older adults with diabetes. We aimed to determine whether lifestyle intervention would improve glycemic control and age-relevant outcomes in older adults with diabetes and comorbidities. A total of 100 older adults with diabetes were randomly assigned to 1-year intensive lifestyle intervention (ILI) (diet and exercise at a facility transitioned into community-fitness centers and homes) or healthy lifestyle (HL) group. The primary outcome was change in HbA1c. Secondary outcomes included glucoregulation, body composition, physical function, and quality of life. Changes between groups were analyzed with mixed-model repeated-measures ANCOVA following the intention-to-treat principle. HbA1c improved more in the ILI than the HL group (mean ± SE -0.8 ± 0.1 vs. 0.1 ± 0.1%), associated with improved insulin sensitivity (1.2 ± 0.2 vs. -0.4 ± 0.2) and disposition (26.0 ± 8.9 vs. -13.0 ± 8.4 109 min-1) indices (between-group P < 0.001 to 0.04). Body weight and visceral fat decreased more in the ILI than HL group (-8.4 ± 0.6 vs. -0.3 ± 0.6 kg, P < 0.001, and -261 ± 29 vs. -30 ± 27 cm3, P < 0.001, respectively). Physical Performance Test score increased more in the ILI than HL group (2.9 ± 0.6 vs. -0.1 ± 0.4, P < 0.001) as did VO2peak (2.2 ± 0.3 vs. -1.2 ± 0.2 mL/kg/min, P < 0.001). Strength, gait, and 36-Item Short Form Survey (SF-36) Physical Component Summary score also improved more in the ILI group (all P < 0.001). Total insulin dose decreased in the ILI group by 19.8 ± 4.4 units/day. Adverse events included increased episodes of mild hypoglycemia in the ILI group. A lifestyle intervention strategy is highly successful in improving metabolic and functional health of older adults with diabetes.

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.