SF-36 Mental Component Summary Research Articles

P170 Ixekizumab significantly improved quality of life and joint pain in patients with psoriatic arthritis, nail disease and distal interphalangeal joint involvement from SPIRIT-H2H

Abstract Background/Aims Among adults with psoriatic arthritis (PsA) in the SPIRIT H2H study, 65% had nail psoriasis (PsO) at baseline and of these, 96.2% had simultaneous distal interphalangeal joint (DIP) disease in ≥ 1 digits at baseline. This analysis describes the impact of ixekizumab (IXE) and adalimumab (ADA) on quality of life (QoL), function and joint pain. Methods This post-hoc analysis included patients from SPIRIT-H2H (NCT03151551) treated with either IXE or ADA who had simultaneous nail and DIP involvement (swelling or tenderness) in ≥ 1 digits at baseline. Nail PsO was measured using Nail Psoriasis Severity Index (NAPSI). Joint involvement was measured by tender/swollen joint count scores. Joint pain was measured by patient’s assessment of pain using Visual Analogue Scale (100 mm). QoL measures included Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 Mental and Physical Component Summary Scores (SF-36 MCS/PCS). Patients were evaluated at baseline and Week 4, 8, 12, 16, 24, 32, 40, and 52. Joint pain and SF-36 MCS/PCS changes from baseline were analysed using a mixed effects model of repeated measures. Proportions of patients achieving DLQI ≤1 or HAQ-DI change ≥0.35 (minimal clinically important difference) were analysed using logistic regressions. Non-responder imputation and modified baseline observation carried forward methods were used for missing data. Results 354 SPIRIT-H2H patients had a NAPSI total score >0 and DIP involvement in ≥ 1 digits simultaneously at baseline (IXE, N = 186 and ADA, N = 168). Among them, IXE-treated patients had a significant improvement in joint pain at Week 4 and a larger improvement in joint pain over 52 weeks vs ADA-treated patients. In addition, a larger proportion of IXE-treated patients achieved a DLQI score of 0 or 1, and these statistically significant differences were observed as early as Week 4 and sustained at each visit over 52 weeks. IXE-treated patients also experienced statistically significant improvements in SF-36 MCS at Week 4, 12 and 32 compared to ADA-treated patients; numerically greater improvements in favor of IXE were sustained at all other visits. IXE-treated patients showed a larger improvement in SF-36 PCS over 52 weeks vs ADA-treated patients, and these differences reached statistical significance at Week 24 and 32. Similar proportions of patients treated with IXE or ADA showed a clinically important improvement in HAQ-DI. Conclusion In patients with simultaneous nail and DIP involvement in ≥ 1 digit at baseline, IXE treatment resulted in significant improvements across multiple QoL measures, and greater improvements in joint pain compared to ADA treatment. These data may help health care providers make clinical decisions concerning the care of PsA in patients with nail and DIP involvement. Disclosure C. Ritchlin: Consultancies; C. Ritchlin has received consulting fees and/or honoraria and/or grant support from: AbbVie, Bristol-Myers Squibb, Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB Pharma. A. Kavanaugh: Consultancies; A. Kavanaugh has received consulting fees and/or honoraria from: AbbVie, Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB Pharma. L. Kristensen: Consultancies; L.E. Kristensen has received consulting fees and/or honoraria and/or research support from: Pfizer, AbbVie, Amgen, UCB Pharma, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, Janssen. J. Merola: Consultancies; J. F. Merola is a consultant and/or investigator for: Amgen, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly and Company, Novartis, Janssen, UCB Pharma, Sanofi-Regeneron, Sun Pharma, Biogen, Pfizer. B. Strober: Corporate appointments; B. Strober has been serving as an Editor-in-Chief for the Journal of Psoriasis and Psoriatic Arthritis; and serving as scientific co-director and investigator for CorEvitas Psoriasis Registry. Consultancies; B. Strober has served as a speaker for and/or has received consulting fees and/or honoraria from: AbbVie, Alamar, Alumis, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim. Shareholder/stock ownership; reports having stock options in Connect Biopharma, Mindera Health. Honoraria; He is also a consultant for Immunic Therapeutics, Kangpu Pharmaceuticals, Bristol-Myers-Squibb, Connect Biopharma, Dermavant, Evelo Biosciences, Incyte, Janssen, Leo, Eli Lilly and Company, Maruho. Grants/research support; He is also a consultant for Meiji Seika Pharma, Mindera Health, Protagonist, Nimbus, Novartis, Pfizer, UCB Pharma, Sun Pharma, Regeneron, Sanofi-Genzyme, Union Therapeutics, Ventyxbio, vTv Therapeutic. J. Lisse: Consultancies; J. Lisse is employee and stockholder of Eli Lilly and Company. R. Bolce: Shareholder/stock ownership; R. Bolce is employee and stockholder of Eli Lilly and Company. C. Sapin: Shareholder/stock ownership; C. Sapin is employee and stockholder of Eli Lilly and Company. J. Pustizzi: Shareholder/stock ownership; J. Pustizzi is employee and stockholder of Eli Lilly and Company. D. McGonagle: Consultancies; D. McGonagle has received consulting fees and/or honoraria and/or research grants from: AbbVie and Eli Lilly and Company. Grants/research support; His funding sources include or have included the Wellcome Trust-EPSRC, UK NIHR, ARUK, MRC UK and EU FP7 programme.

E071 Bimekizumab demonstrates sustained improvement in quality of life up to week 52 in patients across the full spectrum of axial spondyloarthritis: results from two phase 3 studies

Abstract Background/Aims Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A, has demonstrated rapid and clinically meaningful improvements in disease activity in patients across the full spectrum of axial spondyloarthritis (axSpA; active non-radiographic axSpA [nr-axSpA; BE MOBILE 1, NCT03928704] and ankylosing spondylitis [AS]/ radiographic axSpA [r-axSpA; BE MOBILE 2, NCT03928743]). Here we report health-related quality of life (HRQoL) outcomes (ASQoL, SF-36 and EQ-5D-3L) from the two parallel phase 3 studies up to Week (Wk)52. Methods BE MOBILE 1 and 2 have similar study designs: 16-Wk double-blind placebo (PBO)-controlled period followed by 36-Wk maintenance period. Patients were randomised (1:1 in BE MOBILE 1; 2:1 in BE MOBILE 2) to receive BKZ 160 mg Q4W or PBO. All patients received BKZ 160 mg Q4W from Wk16 to Wk52. We report ASQoL, SF-36 - physical component summary (PCS) and SF-36 - mental component summary (MCS) scores up to Wk52 and proportion of patients with ’no problem’ in each of the 5 EQ- 5D-3L domains (mobility, selfcare, usual activity, pain/discomfort, and anxiety/ depression). The results are presented as observed cases (OC), and missing data were imputed using multiple imputation (MI). Results 254 nr-axSpA (BKZ: 128; PBO: 126) and 332 r-axSpA(BKZ: 221; PBO: 111) patients were randomised with 86.6% and 89.8% completing to Wk52, respectively. At Wk16, BKZ treated patients reported greater improvements in ASQoL and SF-36 PCS compared to PBO (p < 0.001, all comparisons, using Analysis of Covariance [ANCOVA]). By Wk52, these improvements across all HRQoL outcomes were sustained in BKZ treated patients and improved in patients who switched to BKZ at Wk16. (Table). The baseline SF-36 MCS levels indicated that on average patients had normal scores which remained unchanged throughout the study. The proportion of patients reporting ‘no problem’ across all five EQ-5D-3L domains improved over time up to Wk52. In patients with ASQoL ≥4 at baseline, >60% of patients had ≥4-point improvement in ASQoL at Wk52. Conclusion Across the axSpA disease spectrum, treatment with BKZ compared with PBO at Wk16 significantly improved quality of life outcomes measured by EQ-5D-3L, ASQoL and SF-36 PCS scores which were sustained to Wk52. Disclosure N.D. McKay: Consultancies; NDM has received consultancy fees from Gilead and UCB Pharma. Other; NDM has received a registration fees for attendance at a conference from Abbvie, Novartis and UCB Pharma, NDM has received a fee for lecturing from Gilead, NDM has taken part in education meetings, programmes and examinations for a wide range of pharmaceutical companies. A. Bennett: Honoraria; AB received teaching honorarium from Abbvie Ltd, Pfizer, UCB Pharma, Novartis and Biogen. Grants/research support; AB received research grants from Pfizer. Other; AB received advisory board fees from Abbvie Ltd, Pfizer, UCB Pharma, MSD, Novartis and Lilly. N. Goodson: Honoraria; NG has received honoraria from UCB Pharma and Novartis. C. Fleurinck: Other; CF is an employee of UCB Pharma. C. de la Loge: Consultancies; CdlL is a consultant to UCB Pharma, Brussels, Belgium. U. Massow: Other; UM is an employee of UCB Pharma. V. Taieb: Other; VT is employee of UCB Pharma. H. Marzo-Ortega: Grants/research support; HMO has received grants/research support from Janssen, Novartis and UCB Pharma. Other; HMO has received honoraria and/or consultancy and/or speaker fees from Abbvie, Biogen, Celgene, Janssen, Eli-Lilly, Moonlake, Novartis, Pfizer and UCB Pharma. K. Gaffney: Shareholder/stock ownership; KG is a shareholder of Rheumatology Events. Grants/research support; KG has received grants/research support from NASS, Versus Arthritis, AbbVie, Pfizer, UCB Pharma, Norvartis, Eli Lilly, Cellgene, Celltrion, Janssen, Gilead and Biogen. Other; KG has received honoraria/ consultation fees from Novartis, AbbVie, UCB Pharma, Lilly and Pfizer, KG has received speaker’s bureau from Novartis, UCB Pharma, AbbVie and Lilly; meeting expenses from AbbVie, Lilly, Roche, Novartis, Pfizer and UCB Pharma.

Minimum 5-Year Clinical and Return-to-Sport Outcomes After Primary Arthroscopic Scapulothoracic Bursectomy and Partial Scapulectomy for Snapping Scapula Syndrome

Background: Snapping scapula syndrome (SSS) is a rare condition that is oftentimes debilitating. For patients whose symptoms are resistant to nonoperative treatment, arthroscopic surgery may offer relief. Because of the rarity of SSS, reports of clinical outcomes after arthroscopic SSS surgery are primarily limited to small case series and short-term follow-up studies. Purpose: To report minimum 5-year clinical and sport-specific outcomes after arthroscopic bursectomy and partial scapulectomy for SSS and to identify demographic and clinical factors at baseline associated with clinical outcomes at minimum 5-year follow-up. Study Design: Case series; Level of evidence, 4. Methods: Patients who underwent arthroscopic bursectomy and partial scapulectomy for SSS between October 2005 and February 2016 with a minimum of 5 years of postoperative follow-up were enrolled in this single-center study. Clinical outcome scores, including the 12-Item Short Form Health Survey (SF-12), American Shoulder and Elbow Surgeons (ASES) Shoulder Score, shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, Single Assessment Numeric Evaluation (SANE), and visual analog scale (VAS) score for pain, were collected at a minimum 5-year follow-up. Additionally, it was determined which patients reached the minimal clinically important difference. Bivariate analysis was used to determine whether baseline demographic and clinical factors had any association with the outcome scores. Results: Of 81 patients eligible for inclusion in the study, follow-up was obtained for 66 patients (age 33.6 ± 13.3 years; 31 female). At a mean follow-up of 8.9 ± 2.5 years (range, 5.0-15.4 years), all of the outcome scores significantly improved compared with baseline. These included the ASES (from 56.7 ± 14.5 at baseline to 87.2 ± 13.9 at follow-up; P < .001), QuickDASH (from 38.7 ± 17.6 to 13.1 ± 14.6; P < .001), SANE (from 52.4 ± 21.2 to 82.7 ± 19.9; P < .001), SF-12 Physical Component Summary (from 39.7 ± 8.3 to 50.3 ± 8.2; P < .001), SF-12 Mental Component Summary (from 48.2 ± 11.7 to 52.0 ± 9.0; P = 0.014) and VAS pain (from 5.2 ± 2.1 to 1.4 ± 2.0; P < .001). The minimal clinically important difference in the ASES score was reached by 77.6% of the patients. Median postoperative satisfaction was 8 out of 10. It was found that 90.5% of the patients returned to sport, with 73.8% of the patients able to return to their preinjury level. At the time of final follow-up, 8 (12.1%) patients had undergone revision surgery for recurrent SSS symptoms. Older age at surgery (P = .044), lower preoperative SF-12 Mental Component Summary score (P = .008), lower preoperative ASES score (P = .019), and increased preoperative VAS pain score (P = .016) were significantly associated with not achieving a Patient Acceptable Symptom State on the ASES score. Conclusion: Patients undergoing arthroscopic bursectomy and partial scapulectomy for SSS experienced clinically significant improvements in functional scores, pain, and quality of life, which were sustained at a minimum of 5 years and a mean follow-up of 8.9 years postoperatively. Higher patient age, inferior mental health status, increased shoulder pain, and lower ASES scores at baseline were significantly associated with worse postoperative outcomes.

Quality of Life in Patients With Chronic Limb-Threatening Ischemia Treated With Revascularization.

In the BEST-CLI trial (Best Endovascular Versus Best Surgical Therapy for Patients With Chronic Limb-Threatening Ischemia), a prespecified secondary objective was to assess the effects of revascularization strategy on health-related quality of life (HRQoL). Patients with chronic limb-threatening ischemia were randomized to surgical bypass (Bypass) or endovascular intervention (Endo) in 2 parallel trials. Cohort 1 included patients with single-segment great saphenous vein; cohort 2 included those lacking suitable single-segment great saphenous vein. HRQoL was assessed over the trial duration using Vascular Quality-of-Life (VascuQoL), European Quality-of-Life-5D (EQ-5D), the Short Form-12 (SF-12) Physical Component Summary (SF-12 PCS), SF-12 Mental Component Summary (SF-12 MCS), Utility Index Score (SF-6D R2), and numeric rating scales of pain. HRQoL was summarized by cohort and compared within and between groups using mixed-model linear regression. A total of 1193 and 335 patients in cohorts 1 and 2 with a mean follow-up of 2.9 and 2.0 years, respectively, were analyzed. In cohort 1, HRQoL significantly improved from baseline to follow-up for both groups across all measures. For example, mean (SD) VascuQoL scores were 3.0 (1.3) and 3.0 (1.2) for Bypass and Endo at baseline and 4.7 (1.4) and 4.8 (1.5) over follow-up. There were significant group differences favoring Endo when assessed with VascuQoL (difference, -0.14 [95% CI, -0.25 to -0.02]; P=0.02), SF-12 MCS (difference, -1.03 [95% CI, -1.89 to -0.18]; P=0.02), SF-6D R2 (difference, -0.01 [95% CI, -0.02 to -0.001]; P=0.03), numeric rating scale pain at present (difference, 0.26 [95% CI, 0.03 to 0.49]; P=0.03), usual level during previous week (difference, 0.26 [95% CI, 0.04 to 0.48]; P=0.02), and worst level during previous week (difference, 0.29 [95% CI, 0.02 to 0.56]; P=0.04). There was no difference between treatment arms on the basis of EQ-5D (difference, -0.01 [95% CI, -0.03 to 0.004]; P=0.12) or SF-12 PCS (difference, -0.41 [95% CI, -1.2 to 0.37]; P=0.31). In cohort 2, HRQoL also significantly improved from baseline to the end of follow-up for both groups based on all measures, but there were no differences between Bypass and Endo on any measure. Among patients with chronic limb-threatening ischemia deemed eligible for either Bypass or Endo, revascularization resulted in significant and clinically meaningful improvements in HRQoL. In patients with an available single-segment great saphenous vein for bypass, but not among those without one, Endo was statistically superior on some HRQoL measures; however, these differences were below the threshold of clinically meaningful difference.

Patients with neuropsychiatric involvement systemic lupus erythematosus experience poorer health-related quality of life and more fatigue than systemic lupus erythematosus patients with no neuropsychiatric involvement, irrespective of neuropsychiatric activity.

Substantial proportions of patients with systemic lupus erythematosus (SLE) report poor health-related quality of life (HRQoL). Our objective was to investigate the impact of neuropsychiatric involvement (NP) in SLE on patient-reported outcomes. We analysed data from four phase III trials (BLISS-52, BLISS-76, BLISS-SC, EMBRACE; N = 2968). The neuropsychiatric SLE (NPSLE) group comprised individuals with NP-British Isles Lupus Assessment group (BILAG) A/B/C/D or score in any descriptor of the NP-SLEDAI-2K at baseline (N = 350), while the non-NPSLE group consisted of patients with NP-BILAG E (N = 2618). HRQoL was assessed with the SF-36, EQ-5D-3L, and FACIT-F. Full health state (FHS) was defined as "no problems" in all EQ-5D dimensions. NPSLE patients reported lower scores in the SF-36 physical and mental component summary compared with the non-NPSLE population (mean±s.d.: 35.7±9.1 versus 39.6±9.6; p<0.001 and 37.3±12.1 versus 41.4±11.0; p<0.001, respectively). NPSLE patients also exhibited impaired HRQoL in all EQ-5D dimensions compared with non-NPSLE patients (p<0.05 for all). A substantially lower proportion among NPSLE patients experienced FHS in comparison with the non-NPSLE group (3.3% versus 14.5%; p<0.001). NPSLE was associated with severe fatigue (23.8±12.2 versus 31.5±11.6; p<0.001). Notably, our findings revealed no discernible distinctions between active and inactive NPSLE patients with regard to SF-36, EQ-5D, FHS, and FACIT-F scores. Neuropsychiatric involvement in patients with SLE has a detrimental effect on HRQoL experience and is associated with severe fatigue, regardless of the degree of neuropsychiatric disease activity. Early intervention is warranted in NPSLE patients to enhance long-term HRQoL experience.

370 Is There an Optimal Surgical Approach in Degenerative Cervical Myelopathy?: An Individual Participant Data Meta-Analysis

INTRODUCTION: Contradictions exist about impact of anterior vs. posterior surgical approach on outcomes of degenerative cervical myelopathy (DCM). METHODS: Individual patient data of subjects who underwent surgery for DCM was identified from a pooled dataset of the AO Spine CSM-North America, CSM-International, and CSM-Protect clinical studies. Primary outcomes were changes in short form 36 Physical Component Summary score (SF36-PCS) and mJOA score at 12 months. Secondary outcomes were change in total Neck Disability Index (NDI) score and SF36 Mental Component Summary score (SF36-MCS). Two comparison cohorts were created: i) anterior surgery and ii) posterior surgery. One-stage mixed-effects meta-analysis with study and treatment exposure as random effects was performed and reported with mean differences and 95% confidence intervals. A subgroup analysis planned a priori in mild DCM patients (mJOA 15-17) was performed. RESULTS: A total of 979 patients met eligibility criteria. Patients who had anterior decompressive surgery experienced greater improvements at 1yr of follow-up than those who underwent posterior decompressive surgery in SF36-PCS score (adjusted MD 1.57 [95% CI 0.11 to 3.03], p = 0.0348) and NDI score (adjusted MD 3.32 [95% CI 0.58 to 6.05], p = 0.0172). A greater proportion of patients that underwent anterior surgery achieved clinically important recovery of their NDI (OR 1.49 [95% CI 1.15 to 1.93], p = 0.002; aOR 1.46 [95% CI 1.08 to 1.96], p = 0.013) and SF36-PCS scores at 1yr (OR 1.45 [95% CI 1.12 to 1.88], p = 0.004, aOR 1.34 [95% CI 1.00 to 1.80], p = 0.052). In patients with mild DCM (n = 186), patients who underwent anterior decompressive surgery experienced greater improvements in SF36-PCS score, mJOA score, and Neck Disability Index score than posterior surgical patients. CONCLUSIONS: Anterior surgical decompression for DCM is associated with greater improvements in 1yr patient-reported outcomes than posterior surgical decompression.

Factors associated with increased length of stay in degenerative cervical spine surgery: a cohort analysis from the Canadian Spine Outcomes and Research Network.

Postoperative length of stay (LOS) significantly contributes to healthcare costs and resource utilization. The primary goal of this study was to identify patient, clinical, surgical, and institutional variables that influence LOS after elective surgery for degenerative conditions of the cervical spine. The secondary objectives were to examine the variability in LOS and institutional practices used to decrease LOS. This was a multicenter observational retrospective cohort study of patients enrolled in the Canadian Spine Outcomes and Research Network (CSORN) between January 2015 and October 2020 who underwent elective anterior cervical discectomy and fusion (ACDF) (1-3 levels) or posterior cervical fusion (PCF) (between C2 and T2) with/without decompression for degenerative conditions of the cervical spine. Prolonged LOS was defined as LOS greater than the median for the ACDF and PCF populations. The principal investigators at each participating CSORN healthcare institution completed a survey to capture institutional practices implemented to reduce postoperative LOS. In total, 1228 patients were included (729 ACDF and 499 PCF patients). The median (IQR) LOS for ACDF and PCF were 1.0 (1.0) day and 5.0 (4.0) days, respectively. Predictors of prolonged LOS after ACDF were female sex, myelopathy diagnosis, lower baseline SF-12 mental component summary score, multilevel ACDF, and perioperative adverse events (AEs) (p < 0.05). Predictors of prolonged LOS after PCF were nonsmoking status, education less than high school, lower baseline numeric rating scale score for neck pain and EQ5D score, higher baseline Neck Disability Index score, and perioperative AEs (p < 0.05). Myelopathy did not significantly predict prolonged LOS within the PCF cohort after multivariate analysis. Of the 8 institutions (57.1%) with an enhanced recovery after surgery (ERAS) protocol or standardized protocol, only 3 reported using an ERAS protocol specific to patients undergoing ACDF or PCF. Patient and clinical factors predictive of prolonged LOS after ACDF and PCF are highly variable, warranting individual consideration for possible mitigation. Perioperative AEs remained a consistent independent predictor of prolonged LOS in both cohorts, highlighting the importance of preventing intra- and postoperative complications.

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

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

The Impact of Symptoms of Depression, Anxiety, and Low Stress-Coping Capacity on the Effects of Telephone Follow-Up on Recovery Measures After Hysterectomy.

To investigate if symptoms of depression, anxiety, and stress-coping capacity have an impact on the effect of telephone follow-up (TFU) on trajectories of six recovery measures after hysterectomy and influence the occurrence of unplanned telephone contacts (uTCs) and unplanned visits (uVs) to health care providers. A post hoc nonrandomized analysis of participants enrolled in a randomized, four-armed, single-blinded, controlled multicenter intervention study comprising 487 women where the women were allocated 1:1:1:1 to one of four TFU models. The Swedish Postoperative Symptom Questionnaire (SPSQ) and two health-related quality of life questionnaires, the EuroQoL-5 dimension with three levels (EQ-5 D-3 L) and the Short-Form-Health Survey (SF-36) assessed the recovery measures. The six recovery measures consisted of the EQ-5D-3L health index, the SF-36 physical component summary (PCS) and mental component summary (MCS), and the maximum and average pain intensity, and symptom sum score obtained from the SPSQ. Psychological distress was evaluated by the psychometric forms, the Hospital Anxiety and Depression Scale and the Stress Coping Inventory. The occurrence of uTC and uV within the 6 weeks of follow-up was registered. Preoperative anxiety, depression, and stress-coping capacity did not modify the effects of the TFU models on the trajectories of the recovery measures, although anxiety and depression were strongly associated with all six recovery measures. uTCs, but not uVs occurred more often in the women with anxiety. Preoperative anxiety, depression, and stress-coping capacity did not appear to influence the effects of TFU contacts on the recovery measures after hysterectomy. Preoperative anxiety seemed to increase the occurrence of uTC. Clinical Trials Registration: ClinicalTrials.gov (NCT01526668).

Apathy After Stroke: Incidence, Symptom Trajectory, and Impact on Quality of Life and Disability

Apathy is one of the most common symptoms following stroke and is often associated with worse functional outcome and poor quality of life (QoL). The trajectory of apathy symptoms has been previously described, and different trajectories have been identified. We determined group and individual changes in apathy symptomatology from the acute phase until 1 year after stroke. We also examined the association of apathy and depression with disability and QoL 1 year after stroke. We measured apathy in a cohort of ischemic stroke survivors at 4 time points from 0 to 12 months after stroke. The Apathy Evaluation Scale (AES) and Dimensional Apathy Scale (DAS) were administered at each time point. Where possible we obtained apathy measured from carers. Depression was assessed with the Geriatric Depression Scale (GDS). Disability and QoL were assessed with the modified Rankin Scale (mRS) and 36-Item Short Form Survey (SF-36). We examined the cross-sectional and individual trajectory of apathy symptoms in each dimension and looked at associations of apathy and depression soon after stroke with mRS and SF-36 at 1 year. Of 200 participants enrolled, 165 completed apathy measures at 12 months. Patient-rated apathy scores increased in both tests at the group level (AES: χ2(3) = 9.86, p = 0.019; DAS: χ2(3) = 8.49, p = 0.037) and individual level (AES: β = 0.13, p = 0.002; DAS β = 0.13, p = 0.005; DAS: executive β = 0.08, p < 0.001). By contrast, carer-rated apathy did not significantly increase (AES: χ2(3) = 0.75, p = 0.862; DAS: χ2(3) = 2.45, p = 0.484). Apathy scores were associated with worse mRS and SF-36, although most associations were no longer significant when controlling for depression. GDS was associated with worse mRS and SF-36 after controlling for covariates and apathy (mRS: β = 0.08, p = 0.006; SF-36 Mental Component Summary: β = -1.53, p < 0.001; SF-36 Physical Component Summary: β = -0.57, p = 0.016). Self-reported apathy progressively increases after stroke, especially in the executive dimension. Apathy is associated with worse QoL and greater disability, although some of these associations might be mediated by depression.

The Role of Sexual Function in Quality of Life Among Midlife and Older Women: The Study of Women's Health Across the Nation.

Objective: To examine how (1) partnered sexual activity, and (2) sexual functioning, contribute to global quality of life (QOL) and health-related quality of life (HRQL) among midlife and older women, and whether importance of sex modifies these associations. Materials and Methods: Women in the Study of Women's Health Across the Nation (SWAN), a multiethnic/racial cohort study, aged 42-52 at recruitment, were followed for ∼20 years. The Ladder of Life and Short Form-36 physical component summary (PCS) and mental component summary (MCS) assessed Global QOL (N = 3,263) and HRQL (N = 2,576), respectively. Primary predictors were (1) having partnered sexual activity (yes/no), and (2) sexual functioning among those with partnered sexual activity. Sociodemographic, health, lifestyle, and psychosocial covariates were included. Results: Importance of sex modified covariate-adjusted association of having partnered sexual activity with global QOL. Adjusted associations of partnered sexual activity with PCS and MCS were not statistically significant. Sexual functioning, among women with partnered sexual activity, was positively associated with global QOL (adjusted p = 0.03), regardless of importance of sex; unrelated to PCS; but positively associated with MCS (adjusted p = 0.03), particularly when sex was "very/quite important." Conclusions: Partnered sexual activity and better sexual functioning are related to QOL for mid-aged and older women, and are stronger when sex is considered important. Partnered sexual activity and sexual functioning are less consistently related to HRQL when adjusted for covariates, and importance modifies only the association between sexual functioning and MCS. Understanding the importance of sex to midlife and older women contextualizes the impact of sex on QOL.

A PROSPECTIVE RANDOMIZED TRIAL OF OPERATIVE VERSUS NONOPERATIVE MANAGEMENT OF FRACTURES OF THE HUMERAL DIAPHYSIS: THE HUMERAL SHAFT FRACTURE FIXATION (HU-FIX) STUDY

This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture.70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL).At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups.Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr.

What is the effect of preoperative depression on outcomes after minimally invasive surgery for adult spinal deformity? A prospective cohort analysis.

Depression has been implicated with worse immediate postoperative outcomes in adult spinal deformity (ASD) correction, yet the specific impact of depression on those patients undergoing minimally invasive surgery (MIS) requires further clarity. This study aimed to evaluate the role of depression in the recovery of patients with ASD after undergoing MIS. Patients who underwent MIS for ASD with a minimum postoperative follow-up of 1 year were included from a prospectively collected, multicenter registry. Two cohorts of patients were identified that consisted of either those affirming or denying depression on preoperative assessment. The patient-reported outcome measures (PROMs) compared included scores on the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back and leg pain, Scoliosis Research Society Outcomes Questionnaire (SRS-22), SF-36 physical component summary, SF-36 mental component summary (MCS), EQ-5D, and EQ-5D visual analog scale. Twenty-seven of 147 (18.4%) patients screened positive for preoperative depression. The nondepressed cohort had an average of 4.83 levels fused, and the depressed cohort had 5.56 levels fused per patient (p = 0.267). At 1-year follow-up, 10 patients still reported depression, representing a 63% decrease. Postoperatively, both cohorts demonstrated improvement in their PROMs; however, at 1-year follow-up, those without depression had statistically better outcomes based on the EQ-5D, MCS, and SRS-22 scores (p < 0.05). Patients with depression continued to experience higher NRS leg scores at 1-year follow-up (3.63 vs 2.22, p = 0.018). After controlling for covariates, the authors found that depression significantly impacted only 1-year follow-up MCS scores (β = 8.490, p < 0.05). Depressed and nondepressed patients reported similar improvements after MIS surgery, except MCS scores were more likely to improve in nondepressed patients.

Predictive Factors of Pain and Functional Outcome 5 Years Following Total Hip Arthroplasty: A Prospective Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement Cohort Study

BackgroundPrevious reports have identified a number of potential predictors of pain and function after total hip arthroplasty (THA). However, the results of these studies were conflicting, and most had a short follow-up after THA. The purpose of this study was to identify factors predictive of pain and function 5 years after THA. MethodsA multicenter cohort of 7,934 primary unilateral THA patients was prospectively enrolled in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement consortium. Demographic data, comorbidities, and patient-reported outcome measures were collected preoperatively and postoperatively at 5 years, including the Hip Disability and OSteoarthritis Outcome Score (HOOS) pain and activities of daily living (ADL) scores. Multivariate logistic regression models with 95% confidence interval were used to identify independent predictors of pain and function at 5 years. ResultsThe patient dissatisfaction percentage was 8.2% at 5 years after THA. The multivariate regression identified the following predictive factors for the HOOS pain score at 5 years: age, educational level, insurance, smoking, race, Charlson Comorbidity Index, back pain severity, number of other lower extremity painful joints, the Knee Injury and Osteoarthritis Outcome Score pain severity of the ipsilateral knee, preoperative Short-Form Health Survey 36-item (SF-36) mental component summary score, and HOOS pain scores. The multivariate regression identified the following predictor factors for HOOS ADL score at 5 years: body mass index, insurance, smoking, race, back pain severity, number of other lower extremity painful joints, Knee Injury and Osteoarthritis Outcome Score pain severity of ipsilateral knee, preop HOOS ADL, and preoperative SF-36 mental component summary score and SF-36 physical component summary score. ConclusionsOverall, 8.2% of patients were dissatisfied 5 years after primary THA. We have identified a number of factors that predict less improvement in pain and function 5 years after THA. These potentially modifiable factors can be targeted with preoperative patient optimization programs to improve patient outcomes and satisfaction after primary THA. Knowledge of these factors that predict less improvement in pain and function can assist the surgeon and patient during shared decision-making, and in setting appropriate patient expectations preoperatively.

Mobile Critical Care Recovery Program for Survivors of Acute Respiratory Failure

Over 50% of Acute Respiratory Failure (ARF) survivors experience cognitive, physical, and psychological impairments that negatively impact their quality of life (QOL). To evaluate the efficacy of a post-intensive care unit (ICU) program, the Mobile Critical Care Recovery Program (m-CCRP) consisting of a nurse care coordinator supported by an interdisciplinary team, in improving the QOL of ARF survivors. This randomized clinical trial with concealed outcome assessments among ARF survivors was conducted from March 1, 2017, to April 30, 2022, with a 12-month follow-up. Patients were admitted to the ICU services of 4 Indiana hospitals (1 community, 1 county, 2 academic), affiliated with the Indiana University School of Medicine. A 12-month nurse-led collaborative care intervention (m-CCRP) supported by an interdisciplinary group of clinicians (2 intensivists, 1 geriatrician, 1 ICU nurse, and 1 neuropsychologist) was compared with a telephone-based control. The intervention comprised longitudinal symptom monitoring coupled with nurse-delivered care protocols targeting cognition, physical function, personal care, mobility, sleep disturbances, pain, depression, anxiety, agitation or aggression, delusions or hallucinations, stress and physical health, legal and financial needs, and medication adherence. The primary outcome was QOL as measured by the 36-item Medical Outcomes Study Short Form Health Survey (SF-36) physical component summary (PCS) and mental component summary (MCS), with scores on each component ranging from 0-100, and higher scores indicating better health status. In an intention-to-treat analysis among 466 ARF survivors (mean [SD] age, 56.1 [14.4] years; 250 [53.6%] female; 233 assigned to each group), the m-CCRP intervention for 12 months did not significantly improve the QOL compared with the control group (estimated difference in change from baseline between m-CCRP and control group: 1.61 [95% CI, -1.06 to 4.29] for SF-36 PCS; -2.50 [95% CI, -5.29 to 0.30] for SF-36 MCS. Compared with the control group, the rates of hospitalization were higher in the m-CCRP group (117 [50.2%] vs 95 [40.8%]; P = .04), whereas the 12-month mortality rates were not statistically significantly lower (24 [10.3%] vs 38 [16.3%]; P = .05). Findings from this randomized clinical trial indicated that a nurse-led 12-month comprehensive interdisciplinary care intervention did not significantly improve the QOL of ARF survivors after ICU hospitalization. These results suggest that further research is needed to identify specific patient groups who could benefit from tailored post-ICU interventions. ClinicalTrials.gov Identifier: NCT03053245.

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.

Extended Partington procedure for chronic pancreatitis: One-year follow-up results

Abstract Background Over half of the patients who underwent the Partington procedure for painful chronic pancreatitis developed recurrent pain attacks. This occurs because the proximal ducts at the head of the pancreas, often containing stones, are left undrained. To overcome this pitfall, an extended Partington procedure is recommended. The aim of this study was to assess our 1-year follow-up results of the extended Partington procedure in patients with painful chronic pancreatitis. Materials and Methods This prospective study comprises patients undergoing extended Partington procedures who were followed for at least 1 year. Data were collected preoperatively and postoperatively in a fixed-interval fashion at 3 months, 6 months, and 1 year. Results Thirty-one patients underwent assessment. At 1-year follow-up, effective and complete pain relief was achieved in 81% and 55% of patients, respectively. The Izbicki pain score decreased significantly; the median dropped from 47.5 to 4.4. The quality of life using SF-12 physical and mental component summary improved significantly; the medians increased from 41.7 to 93.8, and 47.5 to 86.7, respectively. Endocrine function remained stable. Exocrine insufficiency developed in most patients as a natural progression of chronic pancreatitis. Two patients had complications directly related to surgical procedures (6%). No early postoperative deaths occurred. Conclusions Extended Partington procedure for chronic pancreatitis results in excellent pain relief and quality of life improvement, with a low morbidity rate, and does not worsen pancreatic function. It should replace the original Partington procedure in treating painful chronic pancreatitis.

Physical activity and health-related quality of life in older adults: depression as a mediator

BackgroundPhysical activity(PA) is associated with health-related quality of life (HRQoL) among older adults, and both are associated with mood, such as depression. However, the indirect effects of PA on HRQoL in older adults have not been clearly established. This study explained how different types and intensities of PA were associated with HRQoL while considering the effects of depression in older adults.MethodsA cross-sectional study was conducted with 7,518 community-dwelling older adults aged 60 years and older. PA (leisure-time, household, and work-related), depression, and HRQoL were measured using the Physical Activity Scale for the Elderly (PASE), the 30-item Geriatric Depression Scale (GDS-30), and the 36-Item Short-Form Health Survey (SF-36), respectively. Information on age, gender, education, monthly income, activities of daily living, smoking, and alcohol drinking was also collected. Regression analysis was used to explore the relationship between PA, depression and HRQoL, and a mediation effect test process was used to verify the mediating mechanism of the depression on this relationship.ResultsThe study showed that after adjusting for a set of covariates, SF-36 Physical Component Summary (PCS) scores were negatively associated with depression (B = -2.046, 95% CI [2.584, -1.509]) and positively with PA (p < 0.001). Similarly, SF-36 Mental Component Summary (MCS) scores were negatively associated with depression (B = -11.657, 95% CI [-12.190, -11.124]). In mediation analyses, we found that depression partially mediated the relationship between different types and intensities PA and PCS (moderate leisure-time PA: B = 0.223, 95%CI [0.153,0.293], P < 0.001; vigorous leisure-time PA: B = 0.323, 95%CI [0.232,0.413], P < 0.001; moderate household PA: B = 0.092, 95%CI [0.045,0.139], P < 0.001; vigorous household PA: B = 0.137, 95%CI [0.085,0.190], P < 0.001; work-related PA: B = 0.193, 95%CI [0.658,0.190], P < 0.001) and MCS (moderate leisure-time PA: B = 1.243, 95%CI [1.008,1.479], P < 0.001; vigorous leisure-time PA: B = 1.800, 95%CI [1.585,2.015], P < 0.001; moderate household PA: B = 0.496, 95%CI [0.274,0.718], P < 0.001; vigorous household PA: B = 0.742, 95%CI [0.521,0.963], P < 0.001; work-related PA: B = 1.026, 95%CI [0.819,1.234], P < 0.001).ConclusionsThis study suggested that leisure-time, household, and work-related PA were negatively associated with depression, while positively affecting HRQoL in Chinese older adults. The relationships between different types and intensities of PA and HRQoL were mediated by depression. Interventions aimed at promoting purposeful exercise and different types of PA may have mental health benefits. It is recommended that geriatric health managers and healthcare planners prioritize interventions to help improve PA intensities, alleviate depressive symptoms to promote beneficial effects on HRQoL in older adults.

Effectiveness of longstanding exercise therapy compared with usual care for people with rheumatoid arthritis and severe functional limitations: a randomised controlled trial

ObjectivesTo compare the effectiveness of longstanding (>52 weeks), supervised exercise therapy with usual care in adults with rheumatoid arthritis (RA) and severe functional limitations.MethodsParticipants were randomised 1:1 to the intervention...

Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies.

Improvement in bowel urgency (BU) was associated with better clinical outcomes in phase 3 LUCENT-1 (induction) and LUCENT-2 (maintenance) studies in moderately-to-severely active ulcerative colitis (UC). We assessed association of BU with quality-of-life (QoL) outcomes. LUCENT-1: 1162 patients randomized 3:1 to intravenous mirikizumab 300mg or placebo every 4 weeks (Q4W) for 12 weeks. LUCENT-2: 544 mirikizumab induction responders re-randomized 2:1 to subcutaneous mirikizumab 200mg or placebo Q4W through Week (W) 40 (W52 of continuous treatment). Patients reported BU severity in the past 24 hours using a validated Urgency Numeric Rating Scale (NRS). In patients with baseline Urgency NRS ≥3, the association between BU Clinically Meaningful Improvement (CMI; ≥3-point decrease) and remission (score 0 or 1) with patient-reported outcomes was assessed at W12 and W52. A significantly greater proportion of patients with versus without BU Remission achieved IBDQ remission (W12: 87.3% vs 42.7%, P < .0001; W52: 91.4% vs 45.5%, p < .0001). Similarly, BU Remission was associated with more patients achieving CMI in SF-36 Physical Component Summary (W12: 69.0% vs 44.4%, P < .0001; W52: 77.5% vs 42.1%, P < .0001) and Mental Component Summary (W12: 53.5% vs 41.0%, P = .0019; W52: 62.0% vs 38.3%, P < .0001) scores. At W12 and W52, patients with BU CMI or Remission showed significant improvements in EQ-5D-5L and Work Productivity and Activity Impairment:UC scores. Significant improvements were also seen in fatigue, abdominal pain, and nocturnal stool. In patients with moderately-to-severely active UC, improvement in BU was associated with improved QoL in phase 3 LUCENT-1 and LUCENT-2 studies. LUCENT-1: NCT03518086; LUCENT-2: NCT03524092.