Survey Physical Component Summary Scores Research Articles

Three-Plane Calcaneal Osteotomy With Joint Preservation vs Subtalar Arthrodesis to Treat Painful Calcaneal Fracture Malunions.

Calcaneal fracture malunion (CFM) commonly occurs with multiple pathologic changes and progressive pain and difficulty walking. The purpose of this study was to propose a modified 3-plane joint-preserving osteotomy for the treatment of CFM with subtalar joint incongruence, and to compare its efficacy to subtalar arthrodesis. A retrospective comparative analysis of the data of 56 patients with CFM admitted from January 2017 to December 2022 was performed. Twenty-six patients were in the osteotomy group and 30 in the arthrodesis group. Computed tomographic (CT) scans were used for measurement of the intraarticular steps. Radiologic parameters, visual analog scale (VAS) score for pain, 12-Item Short Form Health Survey (SF-12) mental component summary (MCS) and physical component summary (PCS) scores were compared between the 2 groups of patients to assess the outcome preoperatively and at last follow-up, which averaged 22.6 ± 3.6 months and 27.6 ± 3.6 months for the osteotomy and arthrodesis groups, respectively. Improvements in pain, function, and overall quality of life were obtained in both groups compared with the preoperative values at last follow-up. The VAS and SF-12 scores were similar between the groups at the last follow-up. In the osteotomy group, the average CT scan-measured intraarticular step-offs were significantly reduced from 3.7 ± 1.2 mm to 0.9 ± 0.3 mm. The osteotomy group showed improvement in pronation and supination range of motion (ROM) of the feet (P < .01). The correction of the ankle height and Meary angle were slightly better in the osteotomy group. In this short-term follow-up study, good results were achieved in both joint-preserving osteotomy and subtalar arthrodesis groups for the treatment of CFM with subtalar joint incongruence. The osteotomy group preserved the subtalar joint and achieved improvements in pronation and supination ROM.

One-Stage Tibiotalocalcaneal Arthrodesis for Severe Septic Destruction of the Ankle Joint Using a Retrograde Intramedullary Nail: A Retrospective Cross-sectional Study.

Severe septic destruction of the ankle joint poses a therapeutic challenge but lacks a consensus optimal treatment. Tibiotalocalcaneal arthrodesis (TTCA) is considered a valuable salvage procedure, but the literature remains scarce. Conventional treatment approaches, including 2-stage procedures, have been associated with prolonged recovery times and varying success rates. Many authors prefer classical external fixation in these scenarios, citing concerns that internal implants might pose a risk for recurrent infection. To date, no study has investigated the outcomes of 1-stage surgery using a retrograde intramedullary (IM) nail. The main purpose was to assess the rate of recurrent infection at 2 years following 1-stage TTCA using a retrograde IM nail in severe septic destruction of the ankle joint. Fusion rates and functional outcomes were evaluated as secondary purposes. The clinical and radiologic data of patients who underwent 1-stage TTCA with retrograde IM nail following severe septic destruction of the ankle joint with a minimal follow-up of 2 years were retrospectively analyzed. Reinfection rate, fusion rate, functional outcomes, and complications were evaluated. A total of 25 patients were included with a mean follow-up of 42 months (24-92 months). The mean age was 55 ± 18 years old. At the last follow-up, reinfection occurred in 6 patients (24%) and fusion was obtained in 19 patients (83%). Eight patients (32%) required revision surgery. The mean postoperative modified American Orthopaedic Foot & Ankle Society (AOFAS) score, 12-Item Short Form Health Survey physical and mental component summary scores were respectively 53 ± 19.5, 35.5 ± 11.4, and 46.7 ± 13.5 points. One-stage TTCA with retrograde IM nail appears to be an acceptable alternative in severe septic destruction of the ankle joint, with a high eradication rate of infection and ankle fusion.

6425 Impact Of Adrenalectomy On Mood, Sleep, And Quality Of Life In Patients With Mild Autonomous Cortisol Secretion: A Prospective Longitudinal Study

Abstract Disclosure: J. Saini: None. V. Fell: None. B. Atkinson: None. S. Achenbach: None. I. Bancos: None. Background: Patients with mild autonomous cortisol secretion (MACS) have an impaired quality of life and a higher prevalence of sleep and mood disturbances as compared to patients with nonfunctioning adrenal adenomas. The impact of adrenalectomy on quality of life, mood, and sleep is unclear. Objective: To determine the impact of adrenalectomy on quality of life, sleep, and mood in patients with MACS Methods: We conducted a single-center prospective longitudinal study of adults with MACS scheduled for adrenalectomy and referent subjects evaluated between 2018 and 2023. MACS was defined as serum cortisol&amp;gt;1.8 mcg/dL after 1 mg dexamethasone suppression test in patients with adrenal adenomas and no features of overt hypercortisolism. Referent subjects were included if they had abdominal imaging and had no adrenal disorders. Patients and referent subjects had a baseline and a follow-up evaluation at least 10 months later. Differences were assessed using paired t-tests for (1) Quality of life using Short Form-36 (SF 36) survey (Physical and Mental component summary score), sex and age-adjusted (2) Mood using Beck’s Depression Inventory (BDI) (3) Sleep using Pittsburgh Sleep Quality Index (PSQI). Results: We evaluated 41 patients before and after adrenalectomy, and 31 referent subjects at baseline and follow-up visit, at a similar interval (median 1.6, IQR 1.2-2.0 vs 1.5 years, IQR 1.0-2.2, P=0.759). While sex distribution was similar between the groups (66% vs 84% women, P=0.086), patients with MACS were older than the referent group (median age 57.3, IQR 48.8-66.9 vs 49.0, IQR 41.7-57.9 years, P=0.005). After adrenalectomy, patients improved their mood with a mean decrease of -4.71 (SD: 9.11), P=0.002 on the BDI questionnaire. Patients also demonstrated improvement in the SF-36 mental component score by a mean of 6.48 (SD: 10.97), P&amp;lt;0.001. While the overall SF36 physical component score did not improve after adrenalectomy (1.953 (SD: 11.02), P=0.269), one of the PCS components, role-physical limitation, increased by a mean of 6.25 (SD: 13.03). Patients reported better sleep with PSQI score decreasing by a mean of -2.59 (SD: 3.64), P&amp;lt;0.001. No differences in BDI, SF36, and PSQI were observed between baseline and follow-up in referent subjects. Conclusions: After adrenalectomy, patients with MACS showed an improvement in sleep, mood, and mental component of quality of life. Presentation: 6/3/2024

Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial.

Severe tricuspid regurgitation (TR) often causes substantial impairment in patient-reported health status (ie, symptoms, physical and social function, and quality of life), which may improve with transcatheter tricuspid valve replacement (TTVR). We performed an in-depth analysis of health status of patients enrolled in the TRISCEND (Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device) II pivotal trial to help quantify the benefit of intervention to patients. The TRISCEND II pivotal trial randomized 400 patients with symptomatic and severe or greater TR 2:1 to TTVR with the EVOQUE tricuspid valve replacement system plus optimal medical therapy (OMT) or OMT alone. Health status was assessed with the Kansas City Cardiomyopathy Questionnaire and the 36-Item Short Form Health Survey. Changes in health status over 1 year were compared between treatment groups using mixed-effects repeated-measures models. The analysis cohort included 392 patients, of whom 259 underwent attempted TTVR and 133 received OMT alone (mean age 79.2 ± 7.6 years, 75.5% women, 56.1% with massive or torrential TR). Patients had substantially impaired health status at baseline (mean Kansas City Cardiomyopathy Questionnaire Overall Summary Score [KCCQ-OS] 52.1 ± 22.8; mean 36-Item Short Form Health Survey physical component summary score 35.2 ± 8.4). TTVR+OMT patients reported significantly greater improvement in both disease-specific and generic health status at each follow-up time point. Mean between-group differences in the KCCQ-OS favored TTVR+OMT at each time point: 11.8 points (95%CI: 7.4-16.3 points) at 30days, 20.8 points (95%CI: 16.1-25.5 points) at 6months, and 17.8 points (95%CI: 13.0-22.5 points) at 1 year. In subgroup analyses, TTVR+OMT improved health status to a greater extent among patients with torrential or massive TR vs severe TR (treatment effect 23.3 vs 22.6 vs 11.3; interaction P=0.049). At 1 year, 64.6% of TTVR+OMT patients were alive and well (KCCQ-OS≥60 points and no decline of≥10 points from baseline) compared with 31.0% with OMT alone. Compared with OMT alone, treatment of patients with symptomatic and severe or greater TR with TTVR+OMT resulted in substantial improvement in patients' symptoms, function, and quality of life. These benefits were evident 30days after TTVR, continued to increase through 6months, and remained durable through 1 year. (TRISCEND II Pivotal Trial [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device]; NCT04482062).

Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA.

This post hoc analysis of VOLTAIRE-RA compared patient-reported outcomes, including health-related quality of life (HRQoL), in patients with rheumatoid arthritis (RA) before and after treatment with biosimilar adalimumab-adbm or adalimumab reference product. HRQoL was assessed by 36-Item Short Form Survey (SF-36) Physical and Mental Component Summary (PCS and MCS, respectively) and domain scores at baseline and weeks12/24. Results were considered clinically meaningful if improvements were greater than or equal to minimum clinically important differences (MCIDs) of 2.5 for PCS and MCS and 5.0 for domain scores. Comparisons with age- and sex-matched norms and treatment-associated changes in domain scores from baseline were quantified using spydergrams and the health utility SF-6D measure. All comparisons between treatment groups were descriptive in nature. No differences in PCS scores were reported between treatment groups at baseline or weeks12/24. MCS scores slightly favored the reference product group at baseline, and differences in scores at weeks12/24 generally reflected those differences. Improvements in PCS scores greater than or equal to MCID at weeks12/24 were reported by over 65% of patients in both treatment groups, while over 56% experienced improvements in MCS scores greater than or equal to MCID at weeks12/24. Similar proportions receiving reference product and adalimumab-adbm reported scores greater than or equal to US age- and sex-matched normative values at week24: 14-39% versus 15-36%, respectively, compared with baseline (1-17%). In patients with moderate to severely active RA, adalimumab-adbm and adalimumab reference product were both associated with clinically meaningful improvements in SF-36 PCS, MCS, and domain scores that were highly similar at weeks12/24. The high proportion of patients reporting scores greater than or equal to normative values in both treatment groups is notable, as this represents a treatment goal that was difficult to achieve in earlier RA trials. Video abstract available for this article. VOLTAIRE-RA (ClinicalTrials.gov number, NCT02137226; EudraCT number, 2012-002945-40). Video abstract (MP4 29755 KB).

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).

Two-Year Outcomes of Primary Arthroscopic Surgery in Patients with Femoroacetabular Impingement: A Comparative Study of Labral Repair and Labral Reconstruction.

Labral repair has become the preferred method for the arthroscopic treatment of acetabular labral tears that are associated with femoroacetabular impingement (FAI) resulting in pain and dysfunction. Labral reconstruction is performed mainly in revision hip arthroscopy but can be utilized in the primary setting for absent or calcified labra. The purpose of this study was to compare the minimum 2-year patient-reported outcomes (PROs) and risk of revision or conversion to arthroplasty between primary labral reconstruction and primary labral repair. Patients with FAI who underwent primary hip arthroscopy with labral repair or reconstruction performed by the senior author between 2006 and 2018 were identified from a prospectively enrolled patient outcome registry. Exclusion criteria included confounding injuries, dysplasia, prior ipsilateral hip surgery, or a joint space of <2 mm. Patients who were 18 to 80 years old were eligible for inclusion. Multiple regression with inverse propensity score weighting was conducted to estimate the average treatment effect in the treated (ATT) for labral reconstruction versus labral repair with respect to postoperative PROs and the likelihood of subsequent surgery (revision hip arthroscopy or conversion to arthroplasty). PRO end points included the Hip Outcome Score Activities of Daily Living subscale (HOS-ADL), modified Harris hip score, Western Ontario and McMaster Universities Osteoarthritis Index total score (WOMAC), 12-Item Short Form Health Survey Physical Component Summary score (SF-12 PCS), and patient satisfaction. A total of 150 hips undergoing primary labral reconstruction and 998 hips undergoing primary labral repair were included. The median follow-up time was 5.3 years in the reconstruction group and 5.8 years in the repair group. Compared with labral repair, labral reconstruction was associated with a higher risk of conversion to total hip arthroplasty (THA) (20% versus 7%; adjusted odds ratio, 3.2; 95% confidence interval [CI], 1.2 to 8.8; p = 0.024). Inverse propensity score-weighted multiple regression estimated a significant negative effect of labral reconstruction, relative to labral repair, on the postoperative values for the HOS-ADL (ATT, -3.3; 95% CI, -5.8 to -0.7; p = 0.012) and WOMAC (ATT, 2.6; 95% CI, 0.1 to 5.2; p = 0.044). Compared with primary labral reconstruction, primary labral repair resulted in better postoperative HOS-ADL and WOMAC values and decreased conversion to THA. These findings were demonstrated in both the unadjusted group comparisons and multivariable modeling. These data support the use of labral repair in the primary setting of labral tears and the reservation of labral reconstruction for more advanced labral pathology or for revision cases. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

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...

Poster 382: Predictors of Clinical Outcomes and Quality of Life after Sternoclavicular Joint Reconstruction with Hamstring Tendon Autograft

Objectives: Instability of the sternoclavicular joint (SCJ) is a rare but potentially devastating pathologic condition, particularly when it occurs in young or active patients. SCJ reconstruction using hamstring tendon autograft is a commonly used treatment option, yet results are limited to small case series, to date. To date, studies on baseline preoperative demographic factors and their association with postoperative outcome are limited. The objective was to assess the clinical and sport specific outcomes and survivorship after SCJ reconstruction using hamstring tendon autograft in patients suffering from SCJ instability and to determine whether baseline demographic factors were associated with postoperative outcomes or patient satisfaction. Methods: Patients who underwent SCJ reconstruction with a hamstring tendon autograft for SCJ instability between October 2005 and October 2020 were enrolled in this retrospective, monocentric study. At a minimum of 2-years postoperatively, clinical outcomes were collected, including the following patient reported outcomes (PROs): the 12-Item Short Form Survey (SF-12) physical component summary (PCS) and mental component summary (MCS) scores, American Shoulder and Elbow Surgeons (ASES) score, Quick Disabilities of the Arm, Shoulder and Hand (DASH) score, Single Assessment Numeric Evaluation (SANE) score, VAS pain score, VAS pain at worst and subjective postoperative satisfaction with the procedure (0 = very unsatisfied to 10 = very satisfied). Sport specific parameters were investigated via questionnaire. The predictive role of patient demographic factors, including age, sex, and injury in dominant arm, on postoperative PROs and satisfaction at short term follow-up was evaluated using bivariate analysis. According to their respective distribution, continuous variables were compared employing a parametric unpaired t test or the non-parametric Mann–Whitney U test. Categorical variables were compared performing the binary Fisher’s exact test or the Chi-square test. The non-parametric Wilcoxon test for two related samples was used to compare pre- and postoperative values of each outcome parameter. Spearman rank correlations coefficients were calculated in the predictive factor analysis. Results: A total of 49 patients (age: 29.6 ± 16.2 years, range 13.8-67.1, 27 females) were included in the final analysis. Surgery was performed on the dominant shoulder in 26 (63.4%) of the cases. At a mean follow-up of 3.9 ± 2.1 years, all PROs had significantly improved. These included the SF12 PCS (40.4 ± 6.8 to 52.6 ± 6.9, p&lt;0.001), ASES (54.9 ± 20.4 to 91.0 ± 11.3, p&lt;0.001), QuickDASH (41.2 ± 18.5 to 10.2 ± 9.1, p&lt;0.001); SANE (50.2 ± 21.1 to 88.3 ± 8.8, p&lt;0.001), VAS pain (4.4 ± 2.6 to 0.8 ± 1.4, p&lt;0.001) and VAS pain at its worst (7.4 ± 2.5 to 3.3 ± 2.6, p&lt;0.001). The median postoperative satisfaction score was 9 (1-10). Revision-free survivorship was 95.9%. Of those, all patients returned to athletic activity. However only 45% of the overhead athletes returned to their preinjury level. Male patients had a significantly lower VAS pain at worst compared to female patients (2.6 ± 2.6 vs. 4.1 ± 2.4; p=0.045), higher age was significantly correlated with a worse Quick-DASH score (correlation coefficient: 0.314*; p=0.036) and overhead athletes had a significantly lower propensity to return to sports compared to non-overhead athletes (p=0.043). Conclusions: The significant improvements in clinical and sports specific outcomes and high patient satisfaction after SCJ reconstruction with a hamstring autograft demonstrate the success of this procedure in treating SCJ instability. Male sex and younger patient age are associated with superior outcomes, while overhead athletes have to be counseled about difficulties of returning to preinjury level of sport, postoperatively.

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.

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. Patients who underwent ACLR utilizing the HTT technique would achieve excellent patient-reported outcome scores and experience low rates of graft failure and reoperations. Case series; Level of evidence, 4. 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. 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. 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.