SF-36 Physical Component Scale Research Articles

Relative efficacy of prehabilitation interventions and their components: systematic review with network and component network meta-analyses of randomised controlled trials

ObjectiveTo estimate the relative efficacy of individual and combinations of prehabilitation components (exercise, nutrition, cognitive, and psychosocial) on critical outcomes of postoperative complications, length of stay, health related quality of...

Predictors of six-month change in health-related quality of life in people with multiple sclerosis: A secondary data analysis of a randomized controlled trial

BackgroundSymptomatic treatment in people with multiple sclerosis (pwMS) requires multidisciplinary rehabilitation to alleviate disease progression and increasing health-related quality of life (HRQoL). However, the participant- and disease-specific factors that predict sustained improvement in HRQoL in pwMS undergoing inpatient rehabilitation remain unclear. Identifying these factors can help individually tailor inpatient rehabilitation programmes. Therefore, the aim of this study was to identify factors of pwMS at clinic entry for a three-week multidisciplinary inpatient rehabilitation that predict the change in physical and mental HRQoL over six months. MethodsThis is a secondary data analysis of a randomized controlled trial (NCT04356248) conducted at the Valens Rehabilitation Centre, Switzerland. HRQoL was assessed with the Medical Outcome Study 36-item Short Form Health Survey (SF-36) at clinic entry (T0; baseline) and six months after (T3; six-month follow-up). Data for 99 pwMS (mean age in years: 49.60 ± 10.17 SD, mean Expanded Disability Status Scale (EDSS) score: 4.62 ± 1.33 SD, 68.7 % female) were analysed using multiple linear regression. Outcome variables were six-month change in SF-36 Physical (ΔPCS) and Mental Component Scale (ΔMCS) scores. Predictor variables included baseline scores of PCS or MCS, fatigue, anxiety, depressive mood, cardiorespiratory fitness (V̇O2peak/kg), self-efficacy, smoking status, education level, age, EDSS, sex, time since diagnosis and MS phenotype. ResultsThe regression model with ΔPCS as outcome variable explained 18.6 % of the variance of the ΔPCS score (p = .003). Lower PCS score (p < .001) and lower depressive mood (p = .032) at baseline predicted higher ΔPCS score. The regression model with ΔMCS as outcome variable explained 26.8 % of the variance of the ΔMCS score (p < .001). Lower MCS score (p < .001) and longer time since diagnosis (p = .048) at baseline predicted higher ΔMCS score. ConclusionPwMS with lower physical HRQoL and better mood at clinic entry improved most in physical HRQoL over six months. PwMS with lower mental HRQoL and longer time since diagnosis at clinic entry improved most in mental HRQoL over six months. The results of this study contribute to the development of individualized rehabilitation programmes with the aim of maintaining and/or improving HRQoL of pwMS beyond the inpatient rehabilitation stay.

Use of Artificial Intelligence in the Prediction of Chiari Malformation Type 1 Recurrence After Posterior Fossa Decompressive Surgery.

Purpose The purpose of this study was to train a deep learning-based method for the prediction of postoperative recurrence of symptoms in Chiari malformation type 1 (CM1) patients undergoing surgery. Studies suggest that certain radiological and clinical features do exist in patients with treatment failure, though these are inconsistent and poorly defined. Methodology This study was a retrospective cohort study of patients who underwent primary surgical intervention for CM1 from January 2010 to May 2020. Only patients who completed pre- and postoperative 12-item short form(SF-12) surveys were included and these were used to classify the recurrence or persistence of symptoms. Forty patients had an improvement in overall symptoms while 17 had recurrence or persistence. After magnetic resonance imaging (MRI) data augmentation, a ResNet50, pre-trained on the ImageNet dataset, was used for feature extraction, and then clustering-constrained attention multiple instance learning (CLAM), a weakly supervised multi-instance learning framework, was trained for prediction of recurrence. Five-fold cross-validation was used for the development of MRI only, clinical features only, and a combined machine learning model. Results This study included 57 patients who underwent CM1 decompression. The recurrence rate was 30%. The combined model incorporating MRI, pre-operative SF-12 physical component scale (PCS), and extent of cerebellar ectopia performed best with an area under the curve (AUC) of 0.71 and an F1 score of 0.74. Conclusion This is the first study to our knowledge to explore the prediction of postoperative recurrence of symptoms in CM1 patients using machine learning methods and represents the first steptowarddeveloping a clinically useful prognostication machine learning model. Further studies utilizing a similar deep learning approach with a larger sample size are needed to improve the performance.

Responsiveness and sensitivity of PROMs to change in disease activity status in early and established rheumatoid arthritis.

To determine whether patient reported outcome measures (PROMs) capturing activity limitations, health impact, pain, fatigue and work ability are responsive and sensitive to changes in disease activity status in patients with early and established rheumatoid arthritis (RA). All early RA patients (n = 557) from the tREACH-trial and established RA patients (n = 188) from the TARA-trial were included. Both studies were multicentre, single-blinded trials with a treat-to-target management approach. The following PROMs were studied: Health Assessment Questionnaire Disability Index(HAQ-DI), morning stiffness severity, EQ-5D, general health, 36-item short form(SF-36), joint pain, fatigue and productivity loss. Mean changes in PROMs between two consecutive visits were compared with changes in disease activity status(remission, low disease activity and active disease) using linear mixed models and standardised response means. Additionally, the proportion of individual observations that showed an expected PROM response to disease activity status alterations was calculated. HAQ-DI, morning stiffness severity, general health, EQ-5D and joint pain demonstrated responsiveness to improvement or worsening of disease activity status in both early and established RA. SF-36 physical and mental component scale, fatigue and productivity loss did not show this effect in both groups. Across nearly all PROMs, the magnitude of change and the proportion of individual observations that reflect a shift from and to active disease remained low. HAQ-DI, morning stiffness severity, EQ-5D, general health and joint pain are responsive to disease activity status alterations on a group level in both early and established RA. For the individual patient the responsiveness of these PROMs is poor. tREACH trial (www.isrctn.com, ISRCTN26791028) and TARA trial (www.onderzoekmetmensen.nl, NTR2754).

Effects of inpatient energy management education and high-intensity interval training on health-related quality of life in persons with multiple sclerosis: A randomized controlled superiority trial with six-month follow-up.

Fatigue is one of the most frequent symptoms in persons with multiple sclerosis (pwMS) and impacts health-related quality of life (HRQoL). A multidisciplinary rehabilitation approach is recommended for the treatment of fatigue in pwMS. However, high-quality evidence exists only for unimodal interventions, such as physical therapies/exercise or energy/fatigue management programmes. The primary objective of the current study was to test the hypothesis that a combination of inpatient energy management education (IEME) and high-intensity interval training (HIIT) is superior to a combination of progressive muscle relaxation (PMR) and moderate continuous training (MCT) for improving HRQoL at 6-month follow-up in fatigued pwMS. A randomized (1:1) controlled superiority trial with fatigued pwMS >18 years of age, with Expanded Disability Status Scale (EDSS) score ≤6.5, recruited at the Valens clinic, Switzerland. Participants in the experimental group performed IEME twice and HIIT 3 times per week and those in the usual care group performed PMR twice and MCT 3 times per week, during a 3-week inpatient rehabilitation stay. Primary outcome was HRQoL (Physical and Mental Component Scales of the Medical Outcome Study 36-item Short Form Health Survey (SF-36)), assessed at entry to the clinic (T0), after 3 weeks' rehabilitation (T1) and 4 (T2) and 6 (T3) months after T0. Secondary outcomes included SF-36 subscales, fatigue (Fatigue Scale for Motor and Cognitive Functions (FSMC)), mood (Hospital Anxiety and Depression Scale (HADS)), self-efficacy for performing energy conservation strategies (Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)), self-perceived competence in activities of daily living (Occupational Self Assessment (OSA)) and cardiorespiratory fitness (peak oxygen consumption (VȮ2peak)). Data were analysed using a mixed model for repeated measures approach. A total of 106 pwMS (age (years): 49.75 (9.87), 66% female, EDSS: 4.64 (1.32)) were recruited. There were no significant group×time interaction effects in the primary and secondary outcomes. There were significant between-group differences in the pairwise comparisons of the group×time interaction in favour of the IEME+HIIT group at: (i) T1 in cardiorespiratory fitness (p=0.011) and SEPECSA (p=0.032); (ii) T2 in SF-36 mental health subscale (p=0.022), HADS anxiety subscale (p=0.014) and SEPECSA (p=0.040); (iii) T3 in SF-36 physical functioning subscale (p=0.012) and SEPECSA (p=0.003). IEME+HIIT was not superior to PMR+MCT regarding the effects on HRQoL (SF-36 Physical and Mental Component Scales) at 6-month follow-up in pwMS. However, there were significant between-group differences in favour of IEME+HIIT in physical functioning and mental health (SF-36 subscales), anxiety (HADS), cardiorespiratory fitness (VȮ2peak) and self-efficacy (SEPECSA) at different measurement time-points that need to be considered in clinical practice.

Multimorbidity and health-related quality of life amongst Indigenous Australians: A longitudinal analysis

BackgroundThe burden of multimorbidity has been observed worldwide and it has significant consequences on health outcomes. In Australia, health-related quality of life (HRQoL) is comparatively low amongst Aboriginal and/or Torres Strait Islanders, yet no studies have examined the effect of multimorbidity on HRQoL within this at-risk population. This study seeks to fill that gap by employing a longitudinal research design.MethodsLongitudinal data were derived from three waves (9, 13, and 17) of the household, income and labour dynamics in Australia (HILDA) Survey. A total of 1007 person-year observations from 592 Aboriginal and/or Torres Strait Islander individuals aged 15 years and above were included. HRQoL was captured using the 36-item Short-Form Health Survey (SF-36), and multimorbidity was defined using self-reports of having been diagnosed with two or more chronic health conditions. Symmetric fixed-effects linear regression models were used to assess how intraindividual changes in multimorbidity were associated with intraindividual changes in HRQoL.ResultsApproximately 21% of Indigenous Australians were classified as experiencing multimorbidity. Respondents had statistically significantly lower HRQoL on the SF-36 sub-scales, summary measures, and health-utility index in those observations in which they experienced multimorbidity. Among others, multimorbidity was associated with lower scores on the SF-36 physical-component scale (β = − 6.527; Standard Error [SE] = 1.579), mental-component scale (β = − 3.765; SE = 1.590) and short-form six-dimension utility index (β = − 0.075; SE = 0.017).ConclusionThis study demonstrates that having multiple chronic conditions is statistically significantly associated with lower HRQoL amongst Indigenous Australians. These findings suggest that comprehensive and culturally sensitive health strategies addressing the complex needs of individuals with multimorbidity should be implemented to improve the HRQoL of Indigenous Australians.

Impact of previous lumbar spine surgery on the outcome of lumbar total disc replacement: analysis of prospective 5-year follow-up study data.

It is sometimes anticipated that patients with prior spine surgery will have a compromised outcome from future procedures. The purpose of this study was to compare TDR outcomes in patients with prior lumbar spine surgery to those with no previous surgery. Post hoc analysis was performed on 5-year follow-up data collected prospectively in the multi-centre FDA-regulated trial for the activL® Artificial Disc which involved 376 patients treated for single-level symptomatic disc degeneration. Clinical outcome measures included the Oswestry Disability Index (ODI), visual analog scales (VAS) assessing back and leg pain, SF-36, adverse events, and re-operations. Radiographic outcomes included flexion/extension range of motion (ROM) and translation of the operated segment. Patients were divided into two groups: Prior Lumbar Surgery (PLS, n = 92) and No Prior Lumbar Surgery (NPLS, n = 284). Baseline demographics were similar in the two groups. ODI, VAS, and SF-36 Physical Component Scale scores improved significantly (p < 0.05) from baseline in both groups with improvements maintained through 5-year post-TDR with no significant differences between groups. There were no statistically significant differences in rates of serious device-related events, procedure-related events, or re-operations. While ROM was significantly less prior to TDR surgery in the PLS group, there was no significant difference in ROM at post-operative points. Prior lumbar spine surgery was not associated with compromised outcomes following TDR. These results are in line with reports from earlier studies with shorter follow-up, finding that non-destabilizing prior surgery is not a contra-indication for TDR provided that selection criteria are met. Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Relationship between WIfI stage and quality of life at revascularization in the BEST-CLI trial

ObjectiveThe WIfI (Wound, Ischemia, foot Infection) stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with the risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which can be multifactorial. We hypothesized that the severity of the limb threat (WIfI stage) would be associated with poor HRQoL among patients with CLTI presenting for revascularization. MethodsThe dataset of the BEST-CLI (best endovascular versus best surgical therapy in patients with CLTI) trial, a prospective, randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessments at patient enrollment. The HRQoL assessments included (1) Vascular Quality of Life; (2) 12-item short form survey (SF-12), containing the utility index score (short-form six-dimension R2 utility index, incorporating physical, emotional, and mental well-being) and mental and physical components; and (3) the EQ-5D. Multivariable regression analysis was used to identify the independent associations with the baseline HRQoL assessments. ResultsA total of 1568 patients with complete WIfI data were analyzed, of whom 71.5% were men. The WIfI distribution was 35.5% with stage 4, 29.6% with stage 3, 28.6% with stage 2, and 6.3% with stage 1. Patients presenting with WIfI stage 4, compared with stage 1 to 3, were more often men (74.9% vs 69.6%) and current smokers (25.4% vs. 17.6%), had had end-stage renal disease (13.3% vs 8.5%) and diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had had higher median morbidity scores (4 vs 3; P < .05 for all). On multivariable analysis, WIfI stage 4, compared with stage 1 to 3, was associated with lower SF-12 mental component scale scores (estimate, −2.43; 95% confidence interval, −3.73 to −1.13; P < .001) and short-form six-dimension R2 utility index scores (estimate, −0.02; 95% confidence interval, −0.03 to 0.001; P = .04). The WIfI stage was not independently associated with the baseline Vascular Quality of Life, SF-12 physical component scale, or EQ-5D assessments. ConclusionsWIfI stage was independently associated with poorer quality of life because of mental, rather than physical, health for patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with the greatest limb impairment.

Determinants and Clinical Significance of Musculoskeletal Symptoms in Patients With Chronic Graft-Versus-Host Disease.

Musculoskeletal symptoms in chronic graft-versus-host disease (cGVHD) are rare manifestations contributing to disease burden. This study assesses the frequency of muscle cramps, joint and muscle aches, and muscle weakness in a cohort of patients severely affected by cGVHD. Three hundred thirty-four patients participated in the NCI natural history study of cGVHD (NCT00092235) from October 2004 to March 2017. Five-point Lee cGVHD Symptom Scale was dichotomized (less symptom bother—0, 1, 2; severe symptom bother—3, 4) and tested for associations with: Short Form 36 (SF36), 2-minute walk test, grip strength, joint range of motion, and human activity profile, clinical and laboratory data. Seventy-five point four percent of patients reported joint and muscle aches (36.8% severe, Lee Symptom Scale score 3–4), 74.3% muscle cramps (33.5% severe), and 82.34% muscle weakness (45.51% severe), which were associated with reduced functional capacity (SF36 Physical Component Scale, P < 0.0001). Muscle cramps were associated with limited joint movement (P < 0.0001) and skin manifestations (skin thickening, P = 0.0008; itchy skin, P = 0.0003). Muscle cramps did not show association with potential causative agents, such as concomitant calcineurin inhibitors therapy, statins, or use of antidiabetic drugs. Joint and muscle aches showed associations with multiple variables (including strong associations with mood symptoms and fatigue, P < 0.0001). Muscle weakness was not associated with steroid dose, but was significantly associated with depression (P < 0.0001) and anxiety (P = 0.0009). This study documents a high frequency of musculoskeletal symptoms in a cohort of adult patients with cGVHD. The multivariable logistic regression models showed that a joint set of factors were moderately well associated with musculoskeletal symptoms in this study.

P275 Association of the improvement of synovitis and enthesitis with quality of life/patient reported outcomes in patients with psoriatic arthritis treated with ixekizumab

Abstract Background/Aims Psoriatic arthritis (PsA) is an inflammatory rheumatic disease with manifestations including synovitis and enthesitis. During extensive study programs, IXE has shown a treatment effect across domains affected by PsA. Ixekizumab (IXE) is an IL17A inhibitor approved for the treatment of active PsA and axial SpA. We sought to determine whether there is any association between the improvement of synovitis with that of enthesitis from baseline (BL) through week (wk) 52 in patients (pts) with PsA treated with IXE. Additionally, the association between the improvement of synovitis and enthesitis on health-related quality of life and patient-reported outcomes was investigated. Methods Data from SPIRIT-P1 (NCT01695239), SPIRIT-P2 (NCT02349295) and SPIRIT-H2H (NCT03151551) were analysed. These were randomized, phase 3 trials involving pts with active PsA either biologic DMARD-naïve (P1, H2H) or TNF-inhibitor-experienced (P2). We examined the patient population randomised to IXE-treatment (80 mg of ixekizumab every 4 weeks [IXEQ4W]), that had both synovitis and enthesitis at BL. For each study, a standardisation procedure was applied to each study data in order to overcome the differences in score range between LEI and SJC. The Pearson correlation coefficient between improvement from BL in enthesitis and synovitis was calculated at each time point. The mean improvement in the SF-36 Physical Component Summary score [PCS], the Patient’s Global Assessment of Disease Activity [Pt GA], and the EuroQOL five dimensions [EQ5D]-visual analogue [VAS] score) was calculated over time for pts who reached or did not reach resolution of both enthesitis and synovitis at wk 52. Missing data were imputed with modified Baseline Carried Out Forward (mBOCF) for continuous outcomes. Non-responder imputation was used for pts with missing resolution of enthesitis or synovitis. Results At BL, 68 (63% of patients treated with IXEQ4W in the ITT population), 68 (56%) and 159 (56%) pts from P1, P2 and H2H respectively, had both synovitis and enthesitis. In all 3 trials, the standardized mean change from baseline in synovitis and enthesitis showed a similar pattern over time. When statistically significant, Pearson correlation coefficient values ranged from 0.16 to 0.40, indicating a positive association between mean improvement in synovitis and enthesitis. We observed an improvement of SF-36 over the 52 wks regardless of the resolution of synovitis or enthesitis. The most pronounced improvement was shown by pts achieving resolution of both synovitis and enthesitis, followed by the pts achieving one or the other. Conclusion Across the SPIRIT trials, treatment with IXE led to the significant improvement in synovitis and enthesitis with a positive association between the improvement of both. Furthermore, pts that resolved both measures at wk 52 experienced an earlier and greater improvement in the SF-36 Physical Component Scale. Disclosure D. McGonagle: Corporate appointments; D. McGonagle has undertaken research and/or educational program activity with: AbbVie, Celgene, Johnson &amp; Johnson, Merck Sharp &amp; Dohme, Pfizer, and UCB Pharma. L. Kristensen: Consultancies; AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. Member of speakers’ bureau; AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. Grants/research support; Biogen, Janssen Cilag, and UCB Pharma. M. Rudwaleit: Consultancies; AbbVie, Bristol Myers Squibb, Celgene, Chugai Pharmaceutical/Roche, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. H. Kameda: Consultancies; AbbVie, Asahi Kasei Pharma, Astellas, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Novartis, Sanofi, and Takeda. Member of speakers’ bureau; AbbVie, Asahi Kasei Pharma, Astellas, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe Pharma, Novartis, Sanofi, and Takeda. T. Holzkaemper: Shareholder/stock ownership; Eli Lilly and Company. C. El Baou: Other; C. El Baou is an independent contractor working for: Eli Lilly and Company. J. Smolen: Consultancies; AbbVie, Amgen, AstraZeneca, Astro Pharma, Bristol Myers Squibb, Celgene, Celltrion, Chugai Pharmaceutical, Eli Lilly and Company. Grants/research support; Gilead Sciences, GlaxoSmithKline, ILTOO Pharma, Janssen, MedImmune, Merck Sharp &amp; Dohme, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, and UCB Pharma.

Radiofrequency Ablation for Benign Symptomatic Thyroid Nodules in the Netherlands: Successful Introduction of a Minimally Invasive Treatment Option Improving Quality of Life

PurposeTo determine whether adoption of radiofrequency (RF) ablation in patients with symptomatic benign thyroid nodules (SBTNs) in a Dutch regional thyroid network resulted in clinical success and improvement in health-related and thyroid-related quality of life (QoL). Materials and MethodsThe eligibility criteria for RF ablation were as follows: (a) nodule size between 2.0 and 5.0 cm, (b) solid component >20%; (c) benign cytology in 2 separate cytological assessments, and (d) symptoms unequivocally related to mechanical compression. The primary end point of this study was volume reduction 1 year after ablation. The secondary outcomes were health-related and thyroid-related QoL, measured using the short form health survey questionnaire (SF-36) and thyroid-specific patient-reported outcome questionnaire (ThyPRO-39), respectively, as well as adverse event rates. ResultsA total of 72 SBTNs in 67 patients were included. Median age was 50.0 (interquartile range, 41.0–56.0) years, and 91.0% were women. The median volume reduction at 6 weeks, 6 months, 1 year, 2 years, and 3 years was 51.0%, 63.9%, 65.2%, 81.3%, and 90.3%, respectively. The patients showed a significant improvement on the SF-36 physical component scale and ThyPRO-39 overall QoL-impact scale. An absolute improvement was seen in goiter and cosmetic complaints, determined using ThyPRO-39. The overall adverse event rate was 9.0%, of which 4.5% were considered major. ConclusionsRF ablation is an effective treatment option for SBTNs, with a significant volume reduction and improvement in health-related and thyroid-related QoL.

Long-Term Clinical Results of Arthroscopic Lift-Drill-Fill and Fixation (LDFF) Treatment for Osteochondral Lesions of the Talus

Category:Ankle; ArthroscopyIntroduction/Purpose:The purpose of this study was to describe the long-term (> 5 years) clinical results of a novel arthroscopic fixation technique for osteochondral lesions of the talus (OLT), named the Lift, Drill, Fill and Fix (LDFF) technique.Methods:18 ankles (17 patients) underwent an arthroscopic LDFF procedure for a primary OLT. The mean follow-up was 6.8 years (range: 68 - 96 months). Pre- and postoperative clinical assessment was prospectively performed by measuring the Numeric Rating Scale (NRS) of pain at rest, during walking, and when running. Additionally, the Foot and Ankle Outcome Score (FAOS) including its subscores of pain, symptoms, activities of daily living, sports, and quality. Additionally, the Short Form-36 (SF-36) was assessed.Results:The mean NRS during running significantly improved from 7.8 pre-operatively to 3.7 post-operatively (p = 0.006), the NRS during walking from 5.7 to 1.5 (p < 0.001), and the NRS in rest from 2.3 to 1.0 (p = 0.015). The median FAOS at final follow- up was 80 for pain, 57 for other symptoms, 90 for activities of daily living, 70 for sport, and 55 for quality of life. A pre- and post- operative score comparison was available for fifteen patients, and improved significantly in most subscores. The SF-36 physical component scale significantly improved from 42.9 pre-operatively to 50.1 post-operatively.Conclusion:Arthroscopic LDFF of fixable primary OLTs results in excellent pain reduction and improvement of functional outcomes, with sustained results at long-term follow-up. These results indicate surgeons should consider fixation for a fixable OLT.

Does the Distal Level Really Matter in the Setting of Health-Related Quality of Life? Assessment of a Series of Adolescent Idiopathic Scoliosis Patients at More Than 7 Years Following Surgery.

Retrospective longitudinal study. The main goal of this study was to measure the disability after AIS correction, according to the LIV. Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine that may require surgical correction. If the upper and lower instrumented levels (UIV and LIV) of these fusions are defined by the characteristics of the curve, the long-term consequences of the LIV choices are still partially unknown. This retrospective longitudinal study collected demographic, radiologic (Lenke classification, Cobb angle), and surgical data (approach, LIV, UIV) on 116 patients operated for AIS fusion on a specialized pediatric spine center were collected. All participants answered SRS30, SF12, lumbar and leg pain Visual Analogue Scales (VAS) at last follow-up. Statistical analysis between LIV (T12L1, L2, L3 or L4L5) and clinical data at last follow-up was realized. The mean follow-up was 87months. The mean increase of back pain VAS per UIV level was 9 mm. No statistically significant difference between the different LIV was found, for SRS30 or SF12 MCS (mental component scale). There was a statistically significant difference between L3 UIV and L4L5 UIV for SF-12 PCS (physical component scale); ( P = 0.03). The long-term consequences of LIV choice mostly affect levels distal to L3. If the LIV is mostly defined by the characteristics of the curve, one level caudally corresponds to +9 mm of back pain VAS at 7 years of follow-up. Surgeons may be aware of the long-term consequence of LIV choice and patients be informed.

Effects of a Yoga-Based Exercise Program on Health-Related Quality of Life in Breast Cancer Survivors

Research Objectives To examine the impact of six months of exercise on a Health Related Quality of Life (HR-QOL) outcomes in post treatment breast cancer survivors in the San Antonio area in Texas. Design Randomized Controlled Trial. Setting The exercise program was run at a comprehensive cancer care facility. Participants Women with breast cancer (n=94) were randomized into one of three groups: yoga-based exercise (YE; n=31); “conventional” comprehensive exercise (aerobic, resistance and flexibility; CE; n=31); or a comparison group allowing participants to choose their own preferred exercise activities (C; n=32). 72 participants completed the 6 month long exercise program (YE: n=20; CE: n=26 and C: n=26). One year retention testing was completed by 64 participants (YE: n=17; CE: n=21, C: n=24). Interventions All groups exercised three hours weekly over six months. The YE group had a structured Hatha yoga exercise program emphasizing breath awareness and postures. The exercise program for the CE group included aerobic, resistance, and flexibility training. The C group could choose from a variety of activities including aerobics, strength training, Tai Chi, and water aerobics. Main Outcome Measures The SF-36 Physical and Mental Component Scales [PCS, MCS] were used to evaluate HrQoL. Sleep quality was assessed using Pittsburgh Sleep Quality Index (PSQI). SF-36 data was collected at baseline, post and retention. PSQI data was collected baseline and post-intervention only. Results At retention testing, PCS scores improved significantly in the YE group compared C and CE groups (p < 0.025). All participants improved PCS and MCS scores with no between group differences. No change was seen in PSQI scores. Conclusions A yoga-based exercise program can positively impact the physical component of HR-QOL in breast cancer survivors, particularly after completion of the intervention. Whether the HR-QOL continues to improve beyond one year needs further research. Author(s) Disclosures The authors would like to acknowledge all the participants for their commitment to the study and support of Dr. Amy Lang, the ThriveWell Cancer Foundation, and the START Center for Cancer Care. The authors have no other conflicts of interest to declare. To examine the impact of six months of exercise on a Health Related Quality of Life (HR-QOL) outcomes in post treatment breast cancer survivors in the San Antonio area in Texas. Randomized Controlled Trial. The exercise program was run at a comprehensive cancer care facility. Women with breast cancer (n=94) were randomized into one of three groups: yoga-based exercise (YE; n=31); “conventional” comprehensive exercise (aerobic, resistance and flexibility; CE; n=31); or a comparison group allowing participants to choose their own preferred exercise activities (C; n=32). 72 participants completed the 6 month long exercise program (YE: n=20; CE: n=26 and C: n=26). One year retention testing was completed by 64 participants (YE: n=17; CE: n=21, C: n=24). All groups exercised three hours weekly over six months. The YE group had a structured Hatha yoga exercise program emphasizing breath awareness and postures. The exercise program for the CE group included aerobic, resistance, and flexibility training. The C group could choose from a variety of activities including aerobics, strength training, Tai Chi, and water aerobics. The SF-36 Physical and Mental Component Scales [PCS, MCS] were used to evaluate HrQoL. Sleep quality was assessed using Pittsburgh Sleep Quality Index (PSQI). SF-36 data was collected at baseline, post and retention. PSQI data was collected baseline and post-intervention only. At retention testing, PCS scores improved significantly in the YE group compared C and CE groups (p < 0.025). All participants improved PCS and MCS scores with no between group differences. No change was seen in PSQI scores. A yoga-based exercise program can positively impact the physical component of HR-QOL in breast cancer survivors, particularly after completion of the intervention. Whether the HR-QOL continues to improve beyond one year needs further research.

Nutritional Risk at intensive care unit admission and outcomes in survivors of critical illness

Risk factors for poor outcomes after critical illness are incompletely understood. While nutritional risk is associated with mortality in critically ill patients, its association with disability, cognitive, and health-related quality of life is unclear in survivors of critical illness. This study's objective was to determine whether greater nutritional risk at ICU admission is associated with greater disability, worse cognition, and worse HRQOL at 3 and 12-month follow-up. We enrolled adults (≥18 years of age) with respiratory failure or shock treated in medical and surgical intensive care units from two U.S. centers. We measured nutritional risk using the modified Nutrition Risk in Critically Ill (mNUTRIC) score (range 0-9 [highest risk]) at intensive care unit admission. We measured associations between mNUTRIC scores and discharge destination, disability in basic activities of daily living (ADLs) using the Katz ADL, instrumental ADLs using the Functional Activities Questionnaire (FAQ), global cognition using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), executive function using the Trail Making Test Part B (Trails B), and health-related quality of life using the SF-36, adjusting for sex, education, BMI, baseline frailty, disability, and cognition, severity of illness, days of delirium, coma, and mechanical ventilation. Of the 821 patients enrolled in the ICU, 636 patients survived to hospital discharge. We assessed outcomes in 448 of 535 survivors (84%) at 3 months and 382 of 476 survivors (80%) at 12 months. Higher mNUTRIC scores predicted greater odds of discharge to an institution (OR 2.0, 95% CI: 1.6 to 2.6; P<0.01). Higher mNUTRIC scores were associated with a trend towards greater disability in basic activities of daily living (IRR 1.3, 95% CI 1.0 to 1.7) at 3 months that did not reach significance (p=0.09) with no association demonstrated at 12 months. There were no associations between mNUTRIC scores and FAQ, RBANS, orTrails B scores. mNUTRIC scores were inconsistently associated with SF-36 physical and mental component scale scores. Greater nutritional risk at ICU admission is associated with disability in survivors of critical illness. Future studies should evaluate interventions in those at high nutritional risk as a means to speed recovery.

Cross-cultural adaption, translation and validation of the Toronto extremity salvage score (TESS) for patients in German-speaking countries.

SummaryObjectiveThe preferred treatment for malignant bone and soft tissue tumors is limb salvage surgery; the Toronto extremity salvage score (TESS) is commonly used to measure physical functioning of the affected extremity. The aims of this study were to translate and culturally adapt the German version of the TESS, as well as to explore its convergent reliability, validity and re-test reliability.Study designPatients (n = 50) 32 lower extremity (LE) and 18 upper extremity (UE) were asked to fill out the German TESS two times (t1: clinical visit, t2: regular email) and the SF-36 once.MethodsThe TESS questionnaires were translated from English into German, back translated into English, and culturally adapted. The reliability was assessed with Cronbach’s alpha (α). The validity was measured with the SF-36 physical component score and TESS using the Spearman rank correlation coefficient (r). Furthermore, the test-retest reliability was calculated with the intraclass correlation coefficient (ICC).ResultsInternal consistency for both questionnaires was excellent (LE t1: α = 0.924, t2: α = 0.952; UE t1: α = 0.957, t2: α = 0.898). A statistically significant correlation was found between the SF-36 physical component scale and the German TESS (LE r = 0.741, UE r = 0.713). The ICC between baseline (t1) and re-test (t2) was 0.952 and 0.871 for the lower and upper extremities, respectively.ConclusionInitial evidence demonstrated that the German TESS is a valid and reliable instrument for use with patients after surgical treatment of malignant bone or soft tissue sarcoma.Supplementary InformationThe online version of this article (10.1007/s00508-021-01865-4) contains supplementary material, which is available to authorized users.

Association of objectively measured physical fitness with health-related quality of life of mid-life women: the FLAMENCO project

Objectives This study aimed to explore the association of physical fitness with health-related quality of life (HRQoL) in mid-life women and to examine the potential independent association of physical fitness components with the physical and mental components from the 36-Item Short-Form Health Survey (SF-36) in this population. Methods This cross-sectional study comprised 183 mid-life women from southern Spain who participated in the FLAMENCO project. Body composition was measured through an impedanciometer, a stadiometer, and dual-energy X-ray absorptiometry. Physical fitness was objectively measured with the Senior Fitness Test battery (cardiorespiratory fitness, flexibility, and dynamic balance/agility) plus handgrip strength (muscle strength). The SF-36 questionnaire was used to assess HRQoL of the participants. Results All the physical fitness components were associated with the SF-36 physical function (all p < 0.05) except for lower-body flexibility. The rest of the physical fitness components showed associations with most of the SF-36 dimensions (all p < 0.05). Dynamic balance/agility and upper-body flexibility were independently associated with the SF-36 physical component scale, explaining 15% and 17% of the SF-36 physical component scale, respectively. Any physical fitness component showed independent associations with the SF-36 mental component scale. Conclusions Greater physical fitness levels are associated with better HRQoL of mid-life women. Dynamic balance/agility and upper-body flexibility were the strongest independent physical fitness components associated with the SF-36 physical component scale.

Association of objectively measured sedentary behavior and physical activity levels with health-related quality of life in middle-aged women: The FLAMENCO project

The aim of the study was to analyze the association of objectively measured sedentary time and physical activity with health-related quality of life in middle-aged women. The present cross-sectional analyses were performed in a total of 182 middle-aged women (52.6 ± 4.6 years old) from the Fitness League Against MENopause COst (FLAMENCO) project. Sedentary time and physical activity were objectively measured through accelerometry. Participants' health-related quality of life was assessed with the Short-Form Health Survey 36 (SF-36). Lower sedentary time was associated with a better SF-36 emotional role (B: -0.03; 95% confidence interval: -0.07 to -0.00). Greater light physical activity was associated with a better SF-36 emotional role (B: 0.04; 95% confidence interval: 0.00-0.08). Greater moderate-vigorous physical activity was associated with a greater SF-36 physical function (B: 0.01; 95% confidence interval: 0.00-0.02) and SF-36 vitality (B: 0.02; 95% confidence interval: 0.00-0.03). Greater vigorous physical activity was associated with a better SF-36 physical function (B: 0.34; 95% confidence interval: 0.02-0.66), SF-36-bodily pain (B: 0.63; 95% confidence interval: 0.02-1.25), and the SF-36 physical component scale (B: 0.20; 95% confidence interval: 0.00-0.39). Greater total physical activity was associated with a better SF-36 emotional role (B: 0.03; 95% confidence interval: 0.00-0.07). Moderate physical activity was not associated with any SF-36 dimension (all, P > 0.05). Spending less time in sedentary behavior and greater physical activity levels, especially vigorous physical activity, are associated with better health-related quality of life in middle-aged women. Vigorous physical activity is associated with a better SF-36 physical component scale, which might mean a reduction in exercise time with similar improvements for women's quality of life.ClinicalTrials.gov Identifier: NCT02358109. Date of registration: 05/02/2015.

The impact of a disease flare during tapering of DMARDs on the lives of rheumatoid arthritis patients

ObjectivesTo determine the impact of a disease flare on patient reported outcome measures (PROMs) in rheumatoid arthritis (RA) patients, who are tapering treatment. MethodsData were used from the TARA trial; a multicenter, randomized controlled trial in which RA patients, with a well-controlled disease (DAS≤2.4 and SJC≤1) for at least 6 months, gradually tapered their DMARDs. PROMs of patients with a flare (DAS>2.4 and/or SJC>1) were compared every three months before and after a flare with their own norm values. Linear Mixed Models were used to investigate whether a disease flare influenced functional ability (HAQ-DI), fatigue (BRAF-MDQ), quality of life (EQ-5D and SF36), anxiety and depression (HADS), morning stiffness, general health (GH) and worker productivity, and if so, the duration was determined. For unemployment and sick leave we used descriptive statistics. ResultsA flare negatively influenced GH, morning stiffness, HAQ-DI, EQ-5D, BRAF-MDQ, and the SF36 physical component scale and this effect lasted >3 months. Except for the HAQ-DI, effect sizes exceeded the minimum clinically important differences (MCIDs). For the physical outcomes effects lasted >6 months. Worker productivity was not significantly affected by a flare. ConclusionA disease flare influenced patients’ lives, the largest effect was seen in the physical outcomes, and lasted 6 months. Although on a group level effect sizes for the separate PROMs were not always significant or larger than specific MCIDs, a disease flare can still be of great importance for individual patients.

Effect of physical activity on depression symptoms in patients with IgA nephropathy.

ObjectiveWe aimed to assess the effects of physical activity (PA) on depression symptoms in patients with IgA nephropathy (IgAN).MethodsWe developed a 6-month personalized PA training program for patients with IgAN. At the beginning and after completion of the training intervention, patients’ cardiopulmonary function was assessed via a spiroergometric study. Prior to the start of and after the intervention, we administered the Beck Depression Inventory-II (BDI-II), Eysenck Personality Questionnaire (EPQ), Quality of Life Index (QLI), Life Satisfaction Index, and Short Form-36 (SF-36) to all participants. Scores of the QLI were used as the dependent variable.ResultsA total of 216 patients were included in our analysis. After completing the PA training program, cardiopulmonary function and depressive symptoms were significantly improved in patients with IgAN, as compared with baseline values. Multiple logistic regression analysis showed that regular PA; extended hemodialysis interval; decreased scores of the BDI-II, EPQ, and SF-36 Mental Component Scale; and increased SF-36 Physical Component Scale scores were independently associated with improved QLI.ConclusionsRegular PA may improve cardiopulmonary function, depression symptoms, and health-related quality of life in patients with IgAN.