SF-36 Physical Component Summary Scores Research Articles

Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1

IntroductionThe aim of this work is to assess the effect of upadacitinib versus adalimumab and placebo on patient-reported outcomes (PROs) in psoriatic arthritis (PsA) patients with inadequate responses to ≥ 1 non-biologic disease-modifying anti-rheumatic drugs (non-bDMARD-IR) in SELECT PsA-1.MethodsIn this placebo- and active comparator, phase 3 randomized, controlled trial, patients received daily upadacitinib 15 or 30 mg, placebo, or adalimumab 40 mg every other week through 56 weeks. At week 24, placebo-assigned patients were rerandomized to upadacitinib 15 or 30 mg. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Short Form 36 Health Survey (SF-36), EQ-5D-5L index score, Bath Ankylosing Spondylitis Disease Activity Index, morning stiffness, Self-Assessment of Psoriasis Symptoms, and Work Productivity and Activity Impairment. Mean changes from baseline in PROs, improvements ≥ minimum clinically important differences (MCID), scores ≥ normative values, and sustained clinically meaningful responses were compared between treatment groups.ResultsAt weeks 12 and 24, upadacitinib treatment resulted in improvements from baseline versus placebo across all PROs as well as improvements versus adalimumab in HAQ-DI and SF-36 Physical Component Summary score (nominal p < 0.05). Improvements in PtGA, pain, and HAQ-DI were reported as early as week 2. At week 12, significantly (nominal p < 0.05) more upadacitinib- versus placebo-treated patients reported improvements ≥ MCID across all PROs including seven SF-36 domains. The proportions of upadacitinib-treated patients reporting clinically meaningful improvements at week 12 were similar to or greater than with adalimumab and sustained through week 56. Significantly (nominal p < 0.05) more upadacitinib-treated (both doses) patients reported scores ≥ normative values at week 12 versus placebo, and scores were generally similar to or greater than adalimumab.ConclusionsUpadacitinib treatment provides rapid, sustained, and clinically meaningful improvements in PROs in non-bDMARD-IR patients with PsA.SELECT-PsA 1 ClinicalTrials.gov number, NCT03104400.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-021-00379-9.

Effect of a Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle on Psychological Well-Being and Quality of Life in Patients with Type 2 Diabetes: The IDES_2 Randomized Clinical Trial

BackgroundPsychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change.ObjectiveThis study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes.MethodsThree hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month’s theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time.ResultsWHO-5 and SF-36 physical and mental component summary (PCS and MCS) scores increased progressively in the INT group and decreased in the CON group, resulting in significant between-group differences (WHO-5: mean difference 7.35 (95% confidence interval (CI) 3.15–11.55), P = 0.0007; PCS 4.20 (95% CI 2.25–6.15), P < 0.0001; MCS 3.04 (95% CI 1.09–4.99), P = 0.0025). Percentage of participants with likely depression decreased in the INT group and increased in the CON group. PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 min·wk−1 of moderate-to-vigorous intensity PA versus those who did not (13.06 (95% CI 7.51–18.61), P < 0.0001), whereas no relationship was detected for QoL.ConclusionA counselling intervention that was effective in promoting a sustained change in PA and sedentary behaviour significantly improved psychological well-being and QoL.Trial RegistrationClinicalTrials.gov; NCT01600937; 10 October 2012.

Patient-Reported Outcomes and Factors Associated with Achieving the Minimal Clinically Important Difference After ACL Reconstruction: Results at a Mean 7.7-Year Follow-up.

Background:Analyzing outcomes and the minimal clinically important difference (MCID) after anterior cruciate ligament reconstruction (ACLR) is of increased interest in the orthopaedic literature. The purposes of this study were to report outcomes after ACLR at medium to long-term follow-up, identify the threshold preoperative outcome values that would be predictive of achieving the MCID postoperatively, and analyze outcome maintenance at medium to long-term follow-up after ACLR.Methods:Active athletes who underwent ACLR were identified in an institutional ACL registry. Patient-reported outcome measures (PROMs) were administered preoperatively and at the 2-year and >5-year postoperative follow-up; measures included the International Knee Documentation Committee (IKDC) form, the 12-item Short Form Health Survey (SF-12) Physical Component Summary (PCS) and Mental Component Summary (MCS), and Lysholm scale. We calculated the MCID from baseline to each of the 2 follow-up periods (2-year and mean 7.7-year). Logistic regression was performed to investigate factors associated with achievement of the MCID.Results:A total of 142 patients (mean follow-up, 7.7 years [range, 6.6 to 9.1 years]) underwent ACLR. The mean age and body mass index at the time of surgery were 27.2 ± 13.0 years and 23.2 ± 3.0 kg/m2, respectively. Final postoperative outcome scores improved significantly from baseline for the IKDC (50.9 ± 14.7 to 87.9 ± 11.2), SF-12 PCS (41.6 ± 8.9 to 55.6 ± 3.2), and Lysholm scale (62.2 ± 17.6 to 90.5 ± 10.3) (p < 0.0001), while the SF-12 MCS did not improve significantly (54.2 ± 8.0 to 54.4 ± 6.0) (p = 0.763). Between 2- and >5-year follow-up, the SF-12 PCS showed significant improvement (54.6 ± 4.5 to 55.6 ± 3.2; p = 0.036), while no change was noted in the IKDC (87.6 ± 11.1 to 87.9 ± 11.2), SF-12 MCS (55.5 ± 5.3 to 54.4 ± 6.0), and Lysholm scale (89.8 ± 10.6 to 90.5 ± 10.3) (p ≥ 0.09). At the time of final follow-up, the MCID was achieved by 94.7% of patients for the IKDC, 80.8% for the Lysholm, 79.0% for the SF-12 PCS, and 28.2% for the SF-12 MCS. At 2-year follow-up, 95.3% of patients were either “very” or “somewhat” satisfied with their surgery, compared with 88.6% at the time of final follow-up.Conclusions:We found a high level of maintained function following ACLR. The IKDC, SF-12 PCS, and Lysholm scores improved significantly after ACLR at the time of final follow-up and were not significantly different between follow-up periods. Approximately 95% and 89% of patients reported being satisfied with the outcome of surgery at the 2-year and final follow-up, respectively.Level of Evidence:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Predictors of Health-Related Quality of Life in Patients with Ankylosing Spondylitis in Southwest China.

PurposeThe purpose of this study was to evaluate health-related quality of life (QoL) and explore its predictors in patients with ankylosing spondylitis (AS) in Southwest China.Patients and MethodsWe recruited AS patients from a tertiary hospital in Chengdu, China. Data were collected by self-reported questionnaires, including sociodemographic and disease-related variables, the Medical Outcomes Study 36-Item Short Form (SF-36), Beck Depression Inventory-Second Edition (BDI-II), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Global score (BAS-G). Stepwise multiple linear regression analysis was used to determine the factors affecting physical component summary (PCS) and mental component summary (MCS) of SF-36.ResultsA total of 125 patients with AS were included in the current study. The PCS, MCS scores of SF-36 were 41.06±9.12, 47.82±9.84, respectively. Stepwise multiple linear regression analysis showed that higher educational level (β=0.237, P<0.001) and income (β=0.141, P=0.017), lower BASDAI (β=−0.195, P=0.006), BASFI (β=−0.317, P<0.001) and BAS-G (β=−0.288, P<0.001) scores were associated with higher PCS scores of SF-36. Higher BDI-II (β=−0.444, P<0.001) and fatigue (β=−0.293, P<0.001) scores were associated with worse MCS scores of SF-36.ConclusionAS patients in Southwest China had impaired health-related QoL. Healthcare providers should take effective strategies to modify the factors affecting health-related QoL, which may prompt disease management and increase QoL.

Associations between the Severity of Sarcopenia and Health-Related Quality of Life in Community-Dwelling Middle-Aged and Older Adults

(1) Background: The aim of this study was to analyze the associations between severity of sarcopenia and health-related quality of life (HRQoL) among community-dwelling middle-aged and older adults. (2) Methods: A cross-sectional study involving 304 older-adult participants was used to assess the severity of sarcopenia by measuring muscle strength (handgrip dynamometer), muscle mass (bioelectrical impedance analysis), and physical performance (Timed Up-and-Go test). The generic 36-item Short-Form Health Survey (SF-36) was used to evaluate HRQoL. Anxiety and depression (Hospital Anxiety and Depression Scale) as well as age were considered as possible confounders. Probable sarcopenia was determined by low muscle strength; confirmed sarcopenia was defined by the presence of both low muscle strength and muscle mass; and severe sarcopenia was defined by low muscle strength and mass along with poor physical performance. (3) Results: The linear regression analysis showed that the presence of probable sarcopenia was associated with the SF-36 domains physical role (adjusted R2 = 0.183), general health (adjusted R2 = 0.290), and social functioning (adjusted R2 = 0.299). As for the SF-36 mental (MCS) and physical (PCS) component summary scores, probable sarcopenia, as well as depression and anxiety, remained associated with MCS (adjusted R2 = 0.518), and these three variables, together with age, were linked to PCS (adjusted R2 = 0.340). (4) Conclusions: Probable sarcopenia, but not confirmed or severe sarcopenia, was independently associated with poor HRQoL. More precisely, it was related to PCS and MCS, as well as to the physical role, general health, and social functioning of SF-36 domains.

Multilevel Minimally Invasive Lumbar Decompression: Clinical Efficacy and Durability to 2 Years.

The clinical efficacy of single-level minimally invasive lumbar decompression and/or microdiscectomy is well established, with improved postoperative functional outcome and pain scores. However, there is a paucity of clinical data supporting the use of minimally invasive (MIS) techniques in a single operation to address pathology at multiple lumbar levels, and this study attempts to address this issue. A retrospective review of prospectively collected data from patients with symptomatic lumbar stenosis and/or disc herniations who underwent multilevel minimally invasive decompression or microdiscectomy from November 2014 to February 2018 was conducted at a single academic medical center. Patient-reported outcome measures (PROMs), including the Oswestry Disability Index (ODI), visual analog scale (VAS) for back and leg pain, 12-Item Short Form Health Survey (SF-12) Physical Component Summary Score (PCS) and Mental Component Summary Score (MCS), and Scoliosis Research Society survey (SRS-30), were prospectively collected before surgery and at 3 months, 6 months, 1 year, and 2 years postoperatively. During the study period, 92 patients received multilevel (≥2 level) MIS lumbar decompression and/or discectomy (69 two level, 21 three level, 2 four level). The mean age at surgery was 69.7 years, and 23 (25%) patients were women. Patient-reported outcomes were significantly improved both in the short and long term except for the SF-12 MCS. Average improvement from baseline was (at 3 months and 2 years, respectively): VAS back, -3.9 and -2.8; VAS leg, -3.6 and -2.6; ODI, -13 and -14.6; SF-12 MCS, 2.8 and -0.3; SF-12 PCS, 6.9 and 10.1; and SRS-30, 0.57 and 0.55. Minimal clinically important difference for the study population was reached for every PROM except SF-12 MCS. Surgical complications occurred in 16 patients (17.4%), and 8 patients (8.6%) required postoperative fusions within 2 years. The use of MIS techniques to perform lumbar decompression and/or discectomy at multiple levels was found to be both clinically effective and durable. Fusion rates remained low 2 years after the index surgery and were consistent with literature data for open procedures. 2.

Patient-reported outcomes with risankizumab versus fumaric acid esters in systemic therapy-naïve patients with moderate to severe plaque psoriasis: a phase 3 clinical trial.

In a phase 3 clinical study, patients from Germany with moderate to severe psoriasis who were naïve to systemic treatment and received risankizumab had greater and more rapid disease improvements compared with those who received fumaric acid esters (FAEs). To evaluate patient-reported outcomes (PROs) in patients treated with risankizumab compared with FAEs. Adult patients were randomized 1:1 to receive either risankizumab 150mg subcutaneous injections at weeks 0, 4 and 16 or FAEs (Fumaderm® ) provided according to the prescribing label. PRO secondary endpoints assessed were Psoriasis Symptom Scale (PSS), Dermatology Life Quality Index (DLQI), 36-Item Short Form Health Survey, version 2 (SF-36v2), Patient Benefit Index (PBI), Hospital Anxiety and Depression Scale (HADS), Patient Global Assessment (PtGA) and European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L). PROs were assessed at weeks 0, 16 and 24. Sixty patients each were randomized to receive risankizumab or FAEs. A significant PSS improvement was observed with risankizumab vs. FAEs at weeks 16 and 24 for total and psoriasis-associated redness, itching and burning scores (P<0.001). DLQI scores were significantly lower (reflecting better health-related quality of life) with risankizumab vs. FAEs, with least squares (LS) mean differences of -7.4 and -7.6 at weeks 16 and 24, respectively (both P<0.001). Patients randomized to risankizumab also had larger improvements in SF-36 Physical and Mental Component Summary scores, HADS anxiety and depression scores, PtGA, and EQ-5D-5L index and visual analogue scale scores (all P≤0.002) at weeks 16 and 24 compared with FAEs. PBI was significantly higher, indicating greater benefit, with risankizumab vs. FAEs, with an LS mean difference of 1.1 and 1.3 at weeks 16 and 24, respectively (both P<0.001). Risankizumab provides significant benefits over FAEs in improving PROs across several dimensions in patients with moderate to severe psoriasis.

Therapeutic Effect of Large Channel Endoscopic Decompression in Lumbar Spinal Stenosis.

Background: Percutaneous endoscopic decompression (PED) is a minimally invasive surgical technique that is now used for not only disc herniation but also lumbar spinal stenosis (LSS). However, few studies have reported endoscopic surgery for LSS. Therefore, we conducted this study to evaluate the outcomes and safety of large channel endoscopic decompression.Methods: Forty-one patients diagnosed with LSS who underwent PED surgery were included in the study. The estimated blood loss, operative time, length of hospital stay, hospital costs, reoperations, complications, visual analogue scale (VAS) score, Oswestry Disability Index (ODI) score, Japanese Orthopaedic Association (JOA) score and SF-36 physical-component summary scores were assessed. Preoperative and postoperative continuous data were compared through paired-samples t-tests. The significance level for all analyses was defined as p < 0.05.Results: A total of 41 consecutive patients underwent PED, including 21 (51.2%) males and 20 (48.8%) females. The VAS and ODI scores decreased from preoperatively to postoperatively, but the JOA and SF-36 physical component summary scores significantly increased. The VAS (lumbar) score decreased from 5.05 ± 2.33 to 0.45 ± 0.71 (P = 0.000); the VAS (leg) score decreased from 5.51 ± 2.82 to 0.53 ± 0.72 (P = 0.000); the ODI score decreased from 52.80 ± 20.41 to 4.84 ± 3.98 (P = 0.000), and the JOA score increased from 11.73 ± 4.99 to 25.32 ± 2.12 (P = 0.000). Only 1 patient experienced an intraoperative complication (2.4%; dural tear), and 1 patient required reoperation (2.4%).Conclusions: Surgical treatment for LSS is to sufficiently decompress and minimize the trauma and complications caused by surgery. This study did not reveal any obvious shortcomings of PED and suggested PED is a safe and effective treatment for LSS.

Effect of multimorbidity patterns on the decline in health-related quality of life: a nationwide prospective cohort study in Japan

ObjectivesLongitudinal studies, which consider multimorbidity patterns, are useful for better clarifying the effect of multimorbidity on health-related quality of life (HRQoL) and for identifying the target population with poorer clinical...

Two-Year Outcomes After Total Ankle Replacement With a Novel Fixed-Bearing Implant.

The Integra Cadence total ankle replacement (TAR) is a fourth-generation anatomic, fixed-bearing implant requiring minimal tibial and talar resection, which has been in clinical use since June 2016. The primary purpose of this study is to assess its short-term clinical and radiographic outcomes after TAR using this prosthesis. This is a prospective case series of consecutive patients that underwent TAR using this novel fourth-generation prosthesis between June 2016 and November 2017. The primary outcome of interest was the Ankle Osteoarthritis Scale (AOS). Secondary outcomes included Short Form Health Survey-36 (SF-36) scores, radiographic alignment, complications, reoperations, and revisions. In total, 69 patients were included in our study. Fifty-one patients (73.9%) required a total of 91 ancillary procedures. Postoperatively, AOS pain scores decreased significantly by an average of 17.8±30.1 points from 45.9±18.2 to 28.4±27.3 (P < .001). AOS disability scores also decreased significantly following surgery by an average of 22.0±30.5 points from 53.9±18.5 to 32.5±27.9 (P < .001). The SF-36 physical component summary score improved 10.4±9.8 points from 33.1±9.1 to 42.6±9.1 (P < .001). Radiographic analysis demonstrated significant improvement to neutral coronal plane alignment, which was achieved in 97% of patients (P < .01) with no cyst formation at 2 years. There was 1 reported complication, 9 reoperations, and no metal or polyethylene component revisions. Overall, the 2-year implant survivorship was 100% in our cohort. Eighteen patients (26.1%) demonstrated fibrous ingrowth of the tibial component. However, outcome scores for these patients did not demonstrate any negative effects. In our hands, this TAR system demonstrated excellent early clinical and radiographic outcomes. Patients reported improved physical health status, pain, and disability in the postoperative period. Total ankle instrumentation allowed for accurate and reproducible implantation with correction of coronal and sagittal plane deformities. Early results for the clinical use of this TAR system are promising, but further long-term prospective outcome studies are necessary. Level IV, case series.

Effect of Teriparatide on pain relief, and quality of life in postmenopausal females with osteoporotic vertebral compression fractures, a retrospective cohort study.

Osteoporotic vertebral compression fracture (OVCF) is a common disease in elderly population, which could cause serious back pain and has a substantial impact on patients' health-related quality of life (HRQoL). The aim of this study was to identify the effect of Teriparatide as a conservative treatment on reducing back pain, and improving quality of life for postmenopausal women with osteoporotic vertebral fractures. In a 12-month, retrospective study, 112 postmenopausal women with OVCFs were assigned to Teriparatide group (20 µg Teriparatide, subcutaneous, once daily, n=38) or control group (500 mg calcium and 400-800 IU Vitamin D per day, oral administration, n=74) according to patients' choices between January 2016 and October 2018. Patient-reported outcomes scores including the visual analogue score (VAS), Oswestry disability index (ODI), and short form 36 questionnaire (SF-36) were assessed at baseline, the 3rd months, the 6th months and 1 year after treatment. Treatments with Teriparatide or calcium plus vitamin D supplements had significant effect on improvement of patients' back pain as well as HRQoL, with significantly reduced VAS and ODI and increased SF-36 physical component summary (PCS) and mental component summary (MCS) scores. At the endpoint, Teriparatide showed better therapeutic effect, with greater reductions in VAS and ODI and more increases in SF-36 PCS and MCS scores. However, more adverse events (AEs) were found in Teriparatide group, but symptoms were relatively mild and of short duration. In postmenopausal women with OVCFs, the consequent persistent back pain and impaired HRQoL, treatment with Teriparatide was associated with more profound therapeutic effects and more AEs compared with calcium plus vitamin D supplements.

Prognosis of C4 dislocation with spinal cord injury following psychological intervention.

ObjectiveTo investigate the effect of psychological intervention on the prognosis of patients with C4 dislocation and spinal cord injury.MethodsWe investigated target patients admitted between 2010 and 2018. Patients’ mental state, quality of life and neurological function at different time points were evaluated to examine the relationship between psychological intervention and recovery and prognosis of acute and critical spinal cord injury.ResultsAll patients showed improvements in clinical symptoms, neurological function and quality of life. Psychological intervention significantly improved Zung Self-Rating Anxiety Scale score, Zung Self-Rating Depression Scale score and SF-36 Mental Component Summary score within 3 months. Japanese Orthopaedic Association neurological function score and SF-36 Physical Component Summary score were significantly improved after 1-year follow-up. Psychological intervention did not improve 2-year survival.ConclusionTimely and professional psychological intervention can eliminate the psychological disorders of C4 dislocation patients with spinal cord injury. This has a positive effect on their quality of life and prognosis.

The Quality of Life and Economic Burden of Erectile Dysfunction.

Erectile dysfunction (ED) is a common disorder in adult males that results in withdrawal from sexual intimacy, psychosocial problems (ie, poor self-esteem, depression, anxiety), decreased work productivity, and reduction in quality of life for both the men suffering from ED and their female partners. A pragmatic literature review was undertaken using PUBMED to identify original research studies published over the past 20 years that assessed the impact of ED on a male’s quality of life, the impact of ED on a female partner’s quality of life, or the economic impact of ED on employers. Twenty studies were selected for inclusion. This review showed that men with ED have a poorer quality of life than men without ED (n=9 studies). Results from a global burden of illness study showed that men with ED report substantially lower SF-36 Mental and Physical Component Summary scores and SF‐6D scores compared to men without ED (p<0.001). Similarly, the partner is also negatively impacted by ED due to relationship difficulties and decreased sexual satisfaction (n=8 studies). Results from the Female Experience of Men’s Attitudes to Life Events and Sexuality study showed that females were significantly less satisfied and engaged in sexual activity less frequently after their partner developed ED (p<0.001). ED also poses a substantial economic burden on employers (n=3 studies). An observational study in men aged 40–70 showed that men with ED had significantly higher rates of absenteeism (2x) and work productivity impairment compared to men without ED (p<0.001). Overall, this contemporary review demonstrated that ED imposes a substantial quality of life burden on men and their female partners as well as a significant economic burden on their employers. These findings underscore the need for more education and awareness of the burden of ED and greater access to appropriate ED treatments to help alleviate this burden.

Contribution of abnormal BMI to adverse health-related quality of life outcomes after a 52-week therapy in patients with SLE.

ObjectivesTo investigate whether abnormal BMI is associated with adverse health-related quality of life (HRQoL) outcome, including severe fatigue, after 52 weeks of standard therapy plus belimumab or placebo in patients with SLE.MethodsWe analysed data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (n = 1684). Adverse HRQoL was defined as SF-36 scores ≤ the fifth percentile in age- and sex-matched US population-based subjects, and FACIT-F scores <30. We compared BMI groups using the Pearson’s χ2 test, and assessed independence with multivariable logistic regression analysis.ResultsOverweight (BMI ≥25 kg/m2) and obese (BMI ≥30 kg/m2) patients showed increased likelihood to exhibit adverse SF-36 physical component summary (OR: 1.8; 95% CI: 1.4, 2.3; P <0.001 and OR: 2.4; 95% CI: 1.8, 3.2; P <0.001, respectively) and FACIT-F (OR: 1.3; 95% CI: 1.1, 1.6; P = 0.010 and OR: 1.5; 95% CI: 1.2, 2.0; P = 0.002, respectively) scores at week 52. Underweight was associated with adverse SF-36 mental component summary scores, also after adjustment for sex, ancestry, age, disease duration, disease activity, organ damage and prednisone dose during the study period (OR: 2.1; 95% CI: 1.2, 3.6; P = 0.007). Addition of belimumab to standard therapy independently protected against adverse SF-36 general health (OR: 0.8; 95% CI: 0.6, 1.0; P = 0.025) and FACIT-F < 30 (OR: 0.8; 95% CI: 0.6, 1.0; P = 0.018).ConclusionOverweight and obesity contributed to adverse physical and mental HRQoL outcomes after therapeutic intervention in SLE patients, and underweight contributed to adverse mental HRQoL outcome. A protective effect of belimumab against adverse general health and severe fatigue was implicated.

WeChat-based education and rehabilitation program in unprotected left main coronary artery disease patients after coronary artery bypass grafting: an effective approach in reducing anxiety, depression, loss to follow-up, and improving quality of life.

This study aimed to investigate the effect of WeChat-based education and rehabilitation program (WERP) on anxiety, depression, health-related quality of life (HRQoL), major adverse cardiac/cerebrovascular events (MACCE)-free survival, and loss to follow-up rate in unprotected left main coronary artery disease (ULMCAD) patients after coronary artery bypass grafting (CABG). In this randomized controlled study, 140 ULMCAD patients who underwent CABG were randomly assigned to WERP group (n=70) or control care (CC) group (n=70). During the 12-month intervention period, anxiety and depression (using hospital anxiety and depression scale (HADS)) and HRQoL (using 12-Item Short-Form Health Survey (SF-12)) were assessed longitudinally. During the total 36-month follow-up period (12-month intervention and 24-month non-intervention periods), MACCE and loss to follow-up were recorded. During the intervention period, HADS-anxiety score at month 9 (M9) (P=0.047) and month 12 (M12) (P=0.034), anxiety rate at M12 (P=0.028), and HADS-D score at M12 (P=0.048) were all reduced in WERP group compared with CC group. As for HRQoL, SF-12 physical component summary score at M9 (P=0.020) and M12 (P=0.010) and SF-12 mental component summary score at M9 (P=0.040) and M12 (P=0.028) were all increased in WERP group compared with CC group. During the total follow-up period, WERP group displayed a trend of longer MACCE-free survival than that in CC group but without statistical significance (P=0.195). Additionally, loss to follow-up rate was attenuated in WERP group compared with CC group (P=0.033). WERP serves as an effective approach in optimizing mental health care and promoting life quality in ULMCAD patients after CABG.

Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination

ObjectivesWe examined patient-reported outcomes (PROs) in The Study of Etanercept And Methotrexate in Patients with Psoriatic Arthritis (PsA); a 48-week, phase 3, randomised controlled trial that compared outcomes with methotrexate...

Association of Autologous Hematopoietic Stem Cell Transplantation in Systemic Sclerosis With Marked Improvement in Health-Related Quality of Life.

To quantify the magnitude, domains, and duration of change in health-related quality of life (HRQoL) in patients with systemic sclerosis (SSc) who underwent autologous hematopoietic stem cell transplantation (HSCT) as compared to SSc patients with similar characteristics who did not undergo autologous HSCT. The study was designed as a retrospective study comparing SSc patients who underwent autologous HSCT and SSc patients who met the criteria for transplantation but were treated with conventional care. Outcomes included scores on the 36-item Short Form (SF-36) health survey and the Health Assessment Questionnaire (HAQ) and its disease-specific symptom scales. Differences in scores between the groups were compared using linear models, adjusting for baseline scores and inverse probability of treatment and censoring weights. In total, 41 SSc patients who underwent autologous HSCT and 65 SSc patients treated with conventional care were compared. In marginal linear weighted models, the SF-36 physical component summary score was a mean ± SEM 7.02 ± 1.94 points higher at the first annual visit (P = 0.001) and 14.40 ± 6.16 points higher at the seventh annual visit (P = 0.03) in patients treated with autologous HSCT compared to the conventional care group. HAQ scores were significantly better in the autologous HSCT group compared to the conventional care group during follow-up (mean ± SEM difference from baseline -0.57 ± 0.13 [P < 0.001] at the first annual visit and -0.94 ± 0.49 [P = 0.07] at the seventh annual visit). There were no differences in the SF-36 mental component summary scores between the 2 groups either at baseline or during follow-up. This study provides robust complementary HRQoL data, including overall and event-free survival data, to expand on the standard repertoire of biomedical variables, thus potentially supporting the physical benefits of autologous HSCT in patients with SSc.

Serum Amyloid A Is a Biomarker of Disease Activity and Health-Related Quality-of-Life in Patients with Antineutrophil Cytoplasmic Antibody-Associated Vasculitis.

Serum amyloid A (SAA) is one of the acute phase proteins synthesized in hepatocytes and secreted by various inflammation or infectious stimuli. We investigated the clinical implication of measuring SAA in patients with antineutrophil cytoplasmic antibody- (ANCA-) associated vasculitis (AAV). Seventy-five patients who had been classified as AAV and enrolled in our prospective observational cohort for AAV patients were included. Clinical and laboratory data were obtained on the day of blood sampling, and SAA was measured by ELISA kits. Birmingham Vasculitis Activity Score (BVAS) and Short-Form 36-Item Health Survey (SF-36) were assessed for disease activity and health-related quality-of-life (HRQoL) measures. We stratified patients into having high BVAS when the BVAS was over the median values, and those with either low SF-36 PCS or low SF-36 MCS were defined as having poor HRQoL. Multivariate logistic regression analysis was conducted to estimate independent predictors of high BVAS. The relative risk (RR) was analyzed using the contingency tables and the chi-squared test. SAA was positively correlated with BVAS (r = 0.642) and FFS (r = 0.367) and was inversely correlated with both the SF-36 physical component summary (r = −0.456) and mental component summary scores (r = −0.394). Furthermore, SAA was significantly correlated with acute phase reactants ESR (r = 0.611) and CRP (r = 0.629). Patients with high BVAS exhibited significantly higher SAA than those with low BVAS (1317.1 ng/mL vs. 423.1 ng/mL). In multivariable logistic regression analysis, serum albumin (odds ratio (OR) 0.132) and SAA > 1173.6 ng/mL (OR 15.132) were independently associated with high BVAS. The risk of having high BVAS and poor HRQoL in patients with SAA > 1173.6 ng/mL was higher than in those with SAA ≤ 1173.6 ng/mL (RR 3.419 and 1.493). Our results suggest that SAA might be a useful biomarker in assessing disease activity and HRQoL in AAV.

The Impact of Preoperative Mental Health and Depression on Outcomes After Total Ankle Arthroplasty.

Preoperative mental health and depression have been shown to negatively impact patient-reported outcome measures after a broad array of orthopaedic procedures including total ankle arthroplasty. The hypothesis for this study was that decreased Short Form (SF)-36 Mental Component Summary (MCS) scores will modulate the impact of depression on patient-reported outcome measures after total ankle arthroplasty. All patients undergoing primary total ankle arthroplasty between January 2007 and December 2016 who were enrolled into a prospective outcomes study and who had at least 1-year minimum study follow-up were retrospectively reviewed. Patients were separated into 4 groups based on the presence or absence of an SF-36 MCS score of <35 points and diagnosis of depression. SF-36 Physical Component Summary (PCS) and MCS scores, Short Musculoskeletal Function Assessment (SMFA) function and bother components, and visual analog scale (VAS) pain were collected preoperatively and in the 1 to 2-year follow-up. The Wilcoxon rank sum was used to assess differences in outcomes by depression and low preoperative MCS scores. Multivariable models were then constructed to evaluate between-group differences in change scores according to preoperative SF-36 MCS scores and a diagnosis of depression, with adjustment for baseline patient and treatment characteristics. Patients with depression and those with low preoperative MCS scores had significantly worse final outcome scores along with reduced improvement in SF-36 PCS and VAS pain scores compared with patients without these risk factors. Among patients with depression, low preoperative MCS scores helped to differentiate patients with poor final outcome scores. Similarly, in patients with low preoperative MCS scores, depression helped to differentiate patients with poor final outcome scores. Although patients achieved significant improvements in functional outcomes regardless of cohort, decreased preoperative mental health modulated the impact of depression on outcomes. Patients with diminished preoperative mental health and depression are at an increased risk for sustaining smaller improvements in outcomes. Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

PIH11 Quality of Life and Economic Burden of Erectile Dysfunction

The objective of this literature review was to characterize the contemporary quality of life (QOL) and economic burden of erectile dysfunction (ED) in men, their partners, and their employers. A literature review was undertaken to identify original research studies published over the past 20 years that assessed the impact of ED on a patient’s QOL, a partner’s QOL, or on work productivity. Studies were included if they focused on any of these domains and reported the comparative burden in participants with ED versus participants without ED. Fifteen studies were selected for inclusion. ED is associated with many psychosocial problems in men such as poor self-esteem, depression, frustration, anxiety, lack of sexual confidence, and limited intimacy. Consequently, men with ED have a poorer QOL than men without ED (n=9 studies). For example, results from a global burden of illness study showed that men with ED report substantially lower SF-36 Mental and Physical Component Summary scores and SF-6D scores compared to men with no ED (p<0.001). Similarly, an ED patient’s partner is also negatively impacted by ED due to relationship difficulties and decreased sexual satisfaction (n=3 studies). Results from the Female Experience of Men’s Attitudes to Life Events and Sexuality study showed that women were significantly less satisfied and engaged in sexual activity less frequently after their partner developed ED (p<0.001). ED also poses a substantial economic burden on employers (n=3 studies). For example, an observational study in men aged 40-70 showed that men with ED had significantly higher rates of absenteeism (2x) and work productivity impairment compared to men without ED (p<0.001). This contemporary review demonstrates that ED imposes a substantial QOL and economic burden on men, their partners, and their employers. There is a need for better management of and access to appropriate ED treatments to help alleviate this burden.