Dimensions Visual Analogue Scale Research Articles

Long term follow-up of a completely metal free total knee endoprosthesis in comparison to an identical metal counterpart

Aseptic loosening is a feared and not yet fully-understood complication of total knee arthroplasty (TKA). Hypersensitivity reactions may be the underlying cause within some susceptible patients. Metal-free implants have been developed as a possible solution. The aim of this prospective, observational long-term study was the assessment of a completely metal-free ceramic knee replacement system compared to its identical metal counterpart 8 years after implantation, conducted as a follow-up of a previous report. A total of 88 patients (mean age 69 years) were enrolled in this prospective, observational long-term 8-year follow-up study. The “ceramic group” with a completely metal-free total knee replacement system was compared to the “conventional group” with an identical metal TKA system at the final follow-up. Clinical assessment included Knee Society Score (KSS), Oxford Knee Score (OKS), European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-L), European Quality of Life 5 Dimension Visual Analogue Scale (EQ-VAS) and High Activity Arthroplasty Score (HAAS) as well as perioperative or postoperative complications and need for revision. The tibial/femoral positioning, signs of periprosthetic fissures/fractures or radiolucent lines were documented radiographically. All postoperative clinical scores in the ceramic group primarily improved from baseline to 4-year follow-up, but then decreased at the final 8-year follow-up. At the final follow-up, statistically non-significant differences were found in comparison of both groups for the KSS (ceramic: 166 ± 31, conventional: 162 ± 29; p > 0.05), OKS (ceramic: 37, conventional: 39; p > 0.05), EQ-VAS (ceramic: 77 ± 17, conventional: 72 ± 18; p > 0.05), and HAAS (ceramic: 8.29 ± 3.32, conventional: 9.28 ± 4.44; p > 0.05). A significant difference was found for EQ-5D-L (ceramic: 0.819 ± 0.284, conventional: 0.932 ± 0.126; p ≤ 0.05). Progressive radiolucent lines have been found around the uncemented tibial stem (0.8 mm at initial diagnosis (mean 19 months); 1.3 mm at 4-year follow-up; 1.6 mm at 8-year follow-up) without any clinical signs of loosening. One revision surgery was performed after a traumatic polyethylene inlay-breakage. No allergic reactions could be detected. The used ceramic TKA system meets the functional performance standards of an established identical metal TKA system after an 8-year follow-up period, offering a safe option for patients with prior hypersensitivity reactions to metallic materials. Full cementation of ceramic components is recommended.

FARS-ADL across Ataxias: Construct Validity, Sensitivity to Change, and Minimal Important Change.

Patient-focused outcomes present a central need for trial-readiness across all ataxias. The Activities of Daily Living part of the Friedreich Ataxia Rating Scale (FARS-ADL) captures functional impairment and longitudinal change but is only validated in Friedreich Ataxia. Validation of FARS-ADL regarding disease severity and patient-meaningful impairment, and its sensitivity to change across genetic ataxias. Real-world registry data of FARS-ADL in 298 ataxia patients across genotypes were analyzed, including (1) cross-correlation with FARS-stage, Scale for the Assessment and Rating of Ataxia (SARA), Patient-Reported Outcome Measure (PROM)-ataxia, and European Quality of Life 5 Dimensions visual analogue scale (EQ5D-VAS); (2) sensitivity to change within a trial-relevant 1-year median follow-up, anchored in Patient Global Impression of Change (PGI-C); and (3) general linear modeling of factors age, sex, and depression (nine-item Patient Health Questionnaire [PHQ-9]). FARS-ADL correlated with overall disability (rhoFARS-stage = 0.79), clinical disease severity (rhoSARA = 0.80), and patient-reported impairment (rhoPROM-ataxia = 0.69, rhoEQ5D-VAS = -0.37), indicating comprehensive construct validity. Also at item level, and validated within genotype (SCA3, RFC1), FARS-ADL correlated with the corresponding SARA effector domains; and all items correlated to EQ5D-VAS quality of life. FARS-ADL was sensitive to change at a 1-year interval, progressing only in patients with worsening PGI-C. Minimal important change was 1.1. points based on intraindividual variability in patients with stable PGI-C. Depression was captured using FARS-ADL (+0.3 points/PHQ-9 count) and EQ5D-VAS, but not FARS-stage or SARA. FARS-ADL reflects both disease severity and patient-meaningful impairment across genetic ataxias, with sensitivity to change in trial-relevant timescales in patients perceiving change. It thus presents a promising patient-focused outcome for upcoming ataxia trials. © 2024 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Tooth Loss as a Predictor of Long-Term Care Requirements in the Elderly: A Study in Kobe City, Japan.

The Kobe project, which utilizes prospective data from the national health insurance system, focuses on early detection and preventive strategies through the Frail Kenshin health check-up program. Previous research has underscored the correlation between tooth loss and the decline in physical and cognitive functions. In this study, using Kobe project data, we examined the link between remaining teeth and long-term care needs in individuals aged 64-65 years, with primary and secondary objectives involving various health parameters and quality of life. We analyzed baseline data from a prospective study conducted alongside the Frail Check program for generally healthy individuals aged 64-65 yearsto examine the relationship between the number of remaining teeth and various health indicators. This study focused on citizens aged 64-65 years to identify those at risk of needing long-term care by the age of 65 years. Data from 1,530 participants were obtained, excluding eight individuals for specific reasons. At the end of the follow-up period, 41 (2.7%) individuals required supportand 15 (1.0%) needed long-term care alone. The data revealed a significant association between the number of remaining teeth and the need for long-term care or support, as demonstrated by the Cochran-Armitage trend test (p<0.001). Although trends were noted for nutrition and total Cognitive Functional Instrument Self scores, they did not reach statistical significance. Additionally, a decrease in the number of remaining teeth was significantly associated with worse European Quality of Life Five Dimensions (EQ-5D-5L) visual analog scale scores, mobility, and regular activities (p<0.001). Tooth loss indicates the potential long-term care needs of older adults. Monitoring oral health is crucial for addressing care requirements.

The Effects of a 'New Generation' of Heat and Moisture Exchangers in Laryngectomized Patients with Previous Heat and Moisture Exchanger Experience.

Objectives: To evaluate the effects of a new generation of heat and moisture exchangers (NG-HMEs) on pulmonary rehabilitation, quality of life, patient satisfaction, and usage patterns. Methods: A prospective observational study on 23 laryngectomized patients with prior HME experience from June 1, 2021 to November 30, 2021. Patients were interviewed at inclusion, after 6 weeks and after 12 weeks after the introduction of NG-HMEs. Two validated questionnaires were used to report pulmonary complaints and quality of life: the Cough and Sputum Assessment Questionnaire (CASA-Q), the European Quality of Life 5 Dimensions Index Score (EQ-5D Index Score), and the European Quality of Life 5 Dimensions Visual Analog Scale (EQ-5D-VAS). Usage patterns and patient satisfaction were reported using study-specific questionnaires. Results: The patients had an average age of 65.7 ± 6.8 years, with 87% being male, on average 33.7 ± 35.3 months after total laryngectomy (TLE). NG-HMEs were used for a mean of 21.87 ± 4.63 hours/day (P = .034). After 12 weeks of use, patients reported the following changes in the CASA-Q domains: cough symptoms (+5; P = .663), cough impact (0; P = .958), sputum symptoms (+8; P = .13), and sputum impact (+3; P = .489). The EQ-5D index score increased (+0.024; P = .917) as well as the EQ-5D VAS (+0.8; P = .27). All patients rated their experience with NG-HMEs with ≥3 out of 5. The patients who used NG-HMEs as instructed (n = 13) reported more profound changes in the CASA-Q domains: cough symptom (+11; P = .129), cough impact (+7; P = .209), sputum symptom (+11; P = .123), and sputum impact (+10; P = .102). Conclusions: Our results show that NG-HMEs could have a positive clinical impact on pulmonary rehabilitation after TLE, even in HME-experienced patients. The use of NG-HMEs does not affect the quality of life. The possible effects of NG-HMEs require further evaluation in long-term studies to fully assess their efficacy.

Cognitive Training With Head-Mounted Display Virtual Reality in Neurorehabilitation: Pilot Randomized Controlled Trial.

Neurological rehabilitation is technologically evolving rapidly, resulting in new treatments for patients. Stroke, one of the most prevalent conditions in neurorehabilitation, has been a particular focus in recent years. However, patients often need help with physical and cognitive constraints, whereby the cognitive domain in neurorehabilitation does not technologically exploit existing potential. Usually, cognitive rehabilitation is performed with pen and paper or on a computer, which leads to limitations in preparation for activities of daily living. Technologies such as virtual reality (VR) can bridge this gap. This pilot study investigated the use of immersive VR in cognitive rehabilitation for patients undergoing inpatient neurorehabilitation. The goal was to determine the difference in rehabilitation effectiveness between a VR serious game that combines everyday activities with cognitive paradigms and conventional computerized cognitive training. We hypothesized the superiority of the VR serious game regarding cognitive abilities and patient-reported outcomes as well as transfer to daily life. We recruited 42 patients with acute brain affection from a German neurorehabilitation clinic in inpatient care with a Mini Mental Status Test score >20 to participate in this randomized controlled trial. Participants were randomly assigned to 2 groups, with 1 receiving the experimental VR treatment (n=21). VR training consisted of daily life scenarios, for example, in a kitchen, focusing on treating executive functions such as planning and problem-solving. The control group (n=21) received conventional computerized cognitive training. Each participant received a minimum of 18 treatment sessions in their respective group. Patients were tested for cognitive status, subjective health, and quality of life before and after the intervention (Alters-Konzentrations-Test, Wechsler Memory Scale-Revised, Trail Making Test A and B, Tower of London-German version, Short Form 36, European Quality of Life 5 Dimensions visual analog scale, and Fragebogen zur Erfassung der Performance in VR). Repeated-measures ANOVA revealed several significant main effects in the cognitive tests: Tower of London-German version (P=.046), Trail Making Test A (P=.01), and Wechsler Memory Scale-Revised (P=.006). However, post hoc tests revealed that the VR group showed significant improvement in the planning, executive control, and problem-solving domains (P=.046, Bonferroni P=.02). In contrast, no significant improvement in the control group between t0 and t1 was detected (all P>.05). Furthermore, a nonsignificant trend was observed in visual speed in the VR group (P=.09, Bonferroni P=.02). The results of this pilot randomized controlled trial showed that immersive VR training in cognitive rehabilitation had greater effectiveness than the standard of care in treating patients experiencing stroke in some cognitive domains . These findings support the further use and study of VR training incorporating activities of daily living in other neurological disorders involving cognitive dysfunction. Federal Registry of Clinical Trials of Germany (DRKS) DRKS00023605; https://drks.de/search/de/trial/DRKS00023605.

Use of latent class analysis and patient reported outcome measures to identify distinct long COVID phenotypes: A longitudinal cohort study.

We sought to 1) identify long COVID phenotypes based on patient reported outcome measures (PROMs) and 2) determine whether the phenotypes were associated with quality of life (QoL) and/or lung function. This was a longitudinal cohort study of hospitalized and non-hospitalized patients from March 2020 to January 2022 that was conducted across 4 Post-COVID Recovery Clinics in British Columbia, Canada. Latent class analysis was used to identify long COVID phenotypes using baseline PROMs (fatigue, dyspnea, cough, anxiety, depression, and post-traumatic stress disorder). We then explored the association between the phenotypes and QoL (using the EuroQoL 5 dimensions visual analogue scale [EQ5D VAS]) and lung function (using the diffusing capacity of the lung for carbon monoxide [DLCO]). There were 1,344 patients enrolled in the study (mean age 51 ±15 years; 780 [58%] were females; 769 (57%) were of a non-White race). Three distinct long COVID phenotypes were identified: Class 1) fatigue and dyspnea, Class 2) anxiety and depression, and Class 3) fatigue, dyspnea, anxiety, and depression. Class 3 had a significantly lower EQ5D VAS at 3 (50±19) and 6 months (54 ± 22) compared to Classes 1 and 2 (p<0.001). The EQ5D VAS significantly improved between 3 and 6 months for Class 1 (median difference of 6.0 [95% CI, 4.0 to 8.0]) and Class 3 (median difference of 5.0 [95% CI, 0 to 8.5]). There were no differences in DLCO between the classes. There were 3 distinct long COVID phenotypes with different outcomes in QoL between 3 and 6 months after symptom onset. These phenotypes suggest that long COVID is a heterogeneous condition with distinct subpopulations who may have different outcomes and warrant tailored therapeutic approaches.

PROMs in Total Hip Arthroplasty: A Comparison between Robotic Mako Assisted Versus Manual Technique

Study Purpose: The purpose of this observational study is to evaluate the degree of satisfaction and improvement in quality of life through PROMs (Patient Related Outcome Measures), which were administered to patients who underwent Total Hip Arthroplasty (THA) by robotic-arm assisted technique (RIO®, MAKO Surgical Corporation). These data were then compared to a sample of patients operated on by standard manual technique. Both groups were operated on by the same surgical team, in the same hospital, and were subjected to the same recommendation and rehabilitation protocols. Surgeries were performed from November 2017 to March 2019 at a hospital in Asl Toscana Sudest. Endpoint of our study is to verify the rate of improvement – which is assumed to be stable one year after surgery – and how the satisfaction rate increases over time. Another aim is to determine – through the use of Forgotten Joint Score questionnaires and the satisfaction scale – whether there is a difference between arthroplasty operated on by standard manual technique vs robotic-assisted method one year after surgery. Method: Patients who undergone robotic-assisted surgery were evaluated before surgery, at discharge, 1, 4 and 12 months after surgery. 70 robotic-assisted THA patients were studied for a whole year, while 31 standard-technique THA patients were evaluated only 12 months after surgery. PROMs post-surgical evaluations occurred during follow-up visits by orthopedists and physiotherapists. Harris Hip Score (HHs), Oxford Hip score (OHS), EQol VAS (Dimension Visual Analogue Scale), LiKert satisfaction scales were used. Likert scale was administered only 4 and 12 months after (no significant results before this time). The Forgotten Joint Scale (FJS) and the satisfaction scale were administered 1 year after surgery both in robotic-assisted and standard manual THA patients (70 robotic-assisted THA vs 31 standard THA). They were operated on in the same period by the same surgical team, with the presence of a senior surgeon, and were subjected to the same rehabilitation protocols by the same team of physiotherapists.Results: 70 robotic-assisted THA were analyzed (30 l, 40r), with a mean age of 63, 76 years. The average hospital stay in acute care settings was 3.07 days. 40 patients then continued in the rehabilitation department after discharge for further 2.98 days. HHs scale gave a value of 54, 94±14, 71 before surgery and 98, 63±2, 54 one year after surgery. OHS scale reported a value of 21, 27±9, 24 before surgery and 47±2, 06 one year after surgery. The EqolVas scale had a value of 56, 23±20, 04 before surgery and 81, 25±15, 84 one year after. 4 months after surgery, the satisfaction rate was 4, 67±0, 61 and 12 months later was 4, 77±0, 54. The FJS scale in 70 robotic-operated patients had a value of 86, 24±21, 1 and it has been compared to a group of 31 standard-operated patients, whose values were 87, 02±16, 57 and P=0,86. 12 months after surgery, the satisfaction rate for robotic-operated patients was 4, 77±0, 54 and 4, 47±0, 83 and P&lt;0, 05 for standard-operated patients, thus statistically significant. Conclusion: Patients undergoing hip arthroplasty surgery all have a high level of expectations and clinical outcomes are very satisfactory, while knee replacements have more limitations and less appreciable results. Some studies regarding THA report more favorable short-to-medium-term outcomes, fewer transfusions, and fewer days of hospital stay by the use of the roboticassisted technique, when compared to the standard manual surgery. Differences in function and quality of life after 1 year from the two types of surgery tend to decrease, although in our study the satisfaction rate of the robotic-assisted surgeries was statistically significant compared to the standard manual technique. Furthermore, it has been noticed that the rate of functional improvement, well-being, satisfaction and quality of life increases over time after surgery. At the first year of follow-up, no statistically significant differences are shown between the robotic-assisted and standard sample concerning the FJS scale.

Exercise for acutely hospitalised older medical patients.

Exercise for acutely hospitalised older medical patients.

A simple method for clinical implications of pain; comprehensive geriatric assessment.

SUMMARYOBJECTIVE:The effect of chronic pain on the elderly population is enormous in terms of both human suffering and cost. This study aimed to investigate the factors associated with chronic low back pain in older adults by performing a comprehensive geriatric assessment.METHODS:This cross-sectional study included 225 elderly patients admitted to a geriatric outpatient clinic. All participants underwent a comprehensive geriatric assessment, and factors related to chronic low back pain were assessed. Participants were grouped as those with and without chronic pain.RESULTS:The mean age of the participants was 72.9±6.9 years, and 149 (66.2%) of them had chronic pain complaints. The number of chronic diseases and medications, depressive symptom scores, and sleep quality scores were higher, and quality of life (European Quality of Life-5 Dimensions index and European Quality of Life-5 Dimensions visual analog scale) and nutritional status scores were lower in the chronic pain group. The pain visual analog scale score had a statistically significant moderate negative correlation with the European Quality of Life-5 Dimensions index (r=-0.440, p=0.000) and European Quality of Life-5 Dimensions visual analog scale (r=-0.398, p=0.000) scores. The male gender was associated with a reduced risk of chronic pain, while poor sleep quality and number of comorbidities were associated with an increased risk of chronic pain (p=0.000, OR 0.20, p=0.021, OR 2.54, and p=0.010, OR 1.40, respectively).CONCLUSION:Chronic pain is common and independently associated with poor sleep quality, an increased number of diseases, and female gender. The results of our study may guide pain management in older individuals.

Exercise With Low-Loads and Concurrent Partial Blood Flow Restriction Combined With Patient Education in Females Suffering From Gluteal Tendinopathy: A Feasibility Study.

IntroductionTo date, there exists no gold standard conservative treatment for lateral hip pain due to tendinopathy of the gluteus medius and/or minimus tendon (GT), a condition often complicated by pain and disability. Higher loads during everyday activities and exercise seems to be contraindicated with GT. The purpose of this study was to evaluate the feasibility of exercise with low-loads concurrent partial blood flow restriction (LL-BFR) and patient education for patients present GT.MethodsRecruitment took place at three hospitals in the Central Denmark Region. The intervention consisted of daily sessions for 8 weeks with one weekly supervised session. From week three patients exercised with applied partial blood flow restriction by means of a pneumatic cuff around the proximal thigh of the affected leg. Throughout the intervention patients received patient education on their hip condition. Sociodemographic and clinical variables were collected at baseline. The feasibility of LL-BFR was conducted by adherence to the exercise protocol and drop-out rate. Patient reported outcome measures (The Victorian Institute of Sport Assessment-Gluteal Questionnaire, EuroQol - 5 Dimensions-Visual Analogue Scale, Oxford Hip Score, Copenhagen Hip and Groin Outcome Score), maximal voluntary isometric hip abduction-, hip extension, and knee extension strength (Nm/kg) measured using a handheld dynamometer, and functional capacity tests (30 second chair-stand test and a stair-climb test) was conducted as secondary outcomes.ResultsSixteen women with a median (IQR) age of 51 (46–60) years were included. Median (IQR) Body Mass Index was 26.69 (23.59–30.46) kg/m2. Adherence to the total number of training sessions and the LL-BFR was 96.4 and 94.4%, respectively. Two patients dropped out due to (i) illness before initiation of LL-BFR and (ii) pain in the affected leg related to the LL-BFR-exercise. At follow-up both pain levels and patient-reported outcome measures improved. Isometric hip abduction-, hip extension-, and knee extension strength on both legs and functional performance increased. Conclusion: LL-BFR-exercise seems feasible for treatment of GT. At follow-up, a high adherence and low drop-out rate were observed. Further, patients reported clinically relevant reductions in pain, and showed significant increases in isometric hip and knee strength.

Low health-related quality of life in hypoparathyroidism and need for PTH analog

ObjectiveHypoparathyroidism (HypoPT) is a rare endocrine disorder in which insufficient levels of parathyroid hormone (PTH) lead to low serum calcium (S-Ca) levels and muscular cramps. The aim was to study the health-related quality of life (HRQoL) and comorbidities in patients with HypoPT compared with the general population and to estimate the need of treatment with PTH analog.DesignPatients with HypoPT were identified and compared with a population sample. Short Form-36 (SF-36) and EuroQol-5 Dimensions Visual Analogue Scale questionnaires were used. All patients were followed up at the Sahlgrenska University Hospital outpatient clinic.MethodsFrom the medical records between 2007 and 2020, 203 patients with HypoPT were identified and compared with a population sample (n = 414) from the World Health Organization’s (WHO) MONICA project, Gothenburg, Sweden. Of the 203 patients who met the diagnostic criteria, 164 were alive and 65% answered the HRQoL questionnaires.ResultsPatients with HypoPT, 80% postsurgical, and controls had similar age (60 years) and sex distribution (80% women). Patients had lower SF-36 summary component scores for physical (40.0 (interquartile range (IQR): 21) vs 51.2 (IQR: 14.6); P < 0.001) and mental (43.1 (IQR:17.4) vs 56.1(IQR:13.3); P < 0.001) well-being, irrespective of etiology or calcium levels. Individuals with HypoPT had more medications and lower renal function but not higher mortality than controls. Low HRQoL together with low calcium was present in 23% of individuals with HypoPT.ConclusionHRQoL was markedly lower in patients with HypoPT than in controls and independent of S-Ca levels. Treatment with PTH analog could be considered at least among patients with both low HRQoL and low calcium levels.

Malnutrition Is an Independent Risk Factor for Low Health-Related Quality of Life Among Centenarians.

Background: To explore the association and understand gender disparities between nutritional status and quality of life among centenarians.Methods: It was a full-sample survey of centenarians conducted in Hainan that included a total of 1,002 eligible centenarians whose age had been verified. The Mini Nutritional Assessment – Short Form (MNA-SF) questionnaire and the EuroQol five dimensions visual analog scale (EQ-5D-VAS) were used to measure participants' nutritional status and quality of life, respectively.Findings: In the 1002 centenarians (822 women and 180 men), 797 (79.5%) (79.5%) reported multimorbidity. The adjusted standardized β estimate association between the MNA-SF and EQ-5D scores was 0.508 in the complete sample. With reference to the normal nutrition group, the standardized β estimate of the association between EQ-5D score and nutritional status were −0.179 and −0.583 for the at risk of malnutrition and malnutrition groups, respectively (both P <0.001). Nutritional status significantly affected the five dimensions of quality of life, particularly mobility and self-care. Compared with the normal nutrition group, the malnutrition group had greater odds of low mobility [Odds ratio (OR)=23.15; 95% CI: 9.81–54.64] and low self-care (OR=24.58; 95% CI: 12.62–47.89). Among males, nutritional status was significantly associated with the usual activities and anxiety/depression dimensions after adjustment. Female participants had results similar to the general population.Interpretation: Malnutrition and being at risk of malnutrition is prevalent among centenarians. Maintaining normal nutritional status is an important protective factor and should receive more attention to improve centenarians' quality of life.

Osteoarthritis in Italy: Impact on Health-Related Quality of Life and Health Care Resources

OBJECTIVE: To determine how osteoarthritis (OA) severity correlates with self-reported outcomes relevant from the patient’s perspective in the Italian clinical setting.METHODS: Data were drawn from the 2017-18 Adelphi OA Disease Specific ProgrammeTM (DSP). Data were collected in the Italian clinical practice settings by primary care physicians, rheumatologists, orthopedists, and their patients with OA, during their regular office visits. Physicians completed information about OA-related visits to healthcare professionals (HCPs), tests/scans conducted, emergency room (ER) visits, surgeries, and OA-related treatment. Physicians also rated patients’ functioning on a 0 to 10 scale (0 = fully functional; 10 = completely impaired). Outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, functional limitations, treatment needs, EuroQoL-5 Dimension (EQ-5D) visual analogue scale (VAS), the work productivity and activity impairment. Descriptive statistics (numbers and percent for categorical variables; means with standard deviations [SD] for continuous variables) were used to evaluate the different variables as appropriate.RESULTS: The study population comprised 900 patients from Italy with knee (40.9%), back (38.7%), hip (27.9%), and/or shoulder (20.3%) OA. Mean age was 66.6 years with a prevalence of female (63%) patients. Patients had mild (26%), moderate (54%), severe (20%) disease severity. Patients with severe disease reported higher functional limitations, greater use of treatments, reduced quality of life, and impaired work productivity and activity. The burdens were higher among elderly and obese patients and in patients with highest pain severity score.CONCLUSIONS: The results from this cross-sectional study show the impact of OA disease severity on all dimensions of health-related quality of life (HRQoL), as well as in OA-related health care resource use.

Quality of Life and Work Productivity Improvements with Upadacitinib: Phase 2b Evidence from Patients with Moderate to Severe Crohn's Disease.

IntroductionIn the phase 2 CELEST study, positive efficacy results were obtained with the Janus kinase 1 inhibitor upadacitinib for adult patients with moderate to severe Crohn’s disease. We present the health-related quality of life and work productivity improvement results with upadacitinib from CELEST.MethodsCELEST (NCT02365649) was a double-blind study where patients were randomized 1:1:1:1:1:1 in the 16-week induction period to placebo or upadacitinib 3 mg twice daily (BID), 6 mg BID, 12 mg BID, 24 mg BID, or 24 mg once daily (QD). Patients completing the induction period were re-randomized 1:1:1 to receive upadacitinib 3 mg BID, 12 mg BID, or 24 mg QD for 36 weeks or 3 mg BID, 6 mg BID, or 12 mg BID (after amendment). Inflammatory Bowel Disease Questionnaire (IBDQ), European Quality of Life-5 Dimensions visual analog scale (EQ-5D VAS), and Work Productivity and Activity Impairment (WPAI) questionnaire outcomes were assessed at baseline and Weeks 8, 16, and 52.ResultsAt Week 16, a significant percentage (P ≤ 0.05) of patients receiving upadacitinib 6-mg BID dose or higher achieved IBDQ response (IBDQ score change ≥ 16 points; 49%–57% for upadacitinib vs. 24% for placebo) and IBDQ remission, except 24 mg QD (IBDQ score ≥ 170; 26%–39% for upadacitinib vs. 11% for placebo). Greater improvements in IBDQ total score, EQ-5D VAS, and activity impairment from baseline (P ≤ 0.1) versus placebo were also observed. Larger improvements (P ≤ 0.1) in IBDQ response and total score and EQ-5D VAS were observed at Week 8 with 6 and 24 mg BID versus placebo, with improvements for all dosages maintained or greater at Week 52 for IBDQ, EQ-5D VAS, and WPAI endpoints, in particular for the 12-mg BID group.ConclusionImprovements in health-related quality of life and work productivity were achieved and sustained with upadacitinib in patients with moderate to severe Crohn’s disease.Trial RegistrationClinicalTrials.gov identifier, NCT02365649.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12325-021-01660-7.

Open reduction and internal fixation of acetabular fractures in patients of old age

Material and methodsThere is an ongoing debate on which treatment for acetabular fractures in elderly patients is the most appropriate. This study was set up to identify the role of open reduction and internal fixation of acetabular fractures in persons of old age.We retrospectively reviewed the medical charts and radiological data of all patients older than 65 years, who suffered an isolated acetabular fracture and were admitted in our Department between 2010 and 2014 (5-year period). Complications, outcome and mortality were recorded. Of all surviving patients, quality of life (QoL), mobility and independence were graded with European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L), European Quality of Life 5 Dimensions Visual Analogue Scale (EQ-5D-VAS), Numeric Rating Scale (NRS), Elderly Mobility Scale (EMS) and Tinetti Mobility Test (TMT).ResultsSeventy patients could be identified. There were 52 men (74%) and 18 women (26%) with a median age of 79.0 years (range: 65–104 years). Forty-six patients (66%) had been treated with open reduction and internal fixation (ORIF), 24 (34%) conservatively. There were negative predictive factors—subchondral impaction, damage to the femoral head and multiple fragments—in 54% of the operative group. With ORIF, an anatomical reduction could be achieved in 27 patients (59%), an acceptable in 18 (39%) and a poor in one (2%). At follow-up, 18 patients (26%) had died and 23 (33%) were not able to participate. The follow-up rate of the surviving operatively treated patients was 77%. Eleven of 46 operated patients (24%) needed a conversion to a total hip arthroplasty (THA). All patients undergoing conversion had imperfect reduction after surgery. No patient in the non-operative group underwent conversion to THA during follow-up. The median follow-up time of operatively treated patients without conversion (n = 17) was 30 months (range, 16–73 months), of patients with THA (n = 9) 30 months after conversion (range, 17–55 months). Quality of reduction correlated to QoL, mobility and independence in all recorded parameters. Patients with secondary THA had similar good outcomes as patients after ORIF without later conversion. Men had better outcome than women.ConclusionORIF of acetabular fractures in patients of old age results in excellent outcomes at short-term follow-up when anatomical reduction can be achieved. In case of negative predictive factors, ORIF cannot be regarded as a definitive solution, rather as the construction of a stable socket for secondary THA. The decision of therapy should be made dependent on pre-operative radiographic parameters.

Coach-Facilitated Web-Based Therapy Compared With Information About Web-Based Resources in Patients Referred to Secondary Mental Health Care for Depression: Randomized Controlled Trial.

BackgroundDepression is a common mental disorder with a high social burden and significant impact on suicidality and quality of life. Treatment is often limited to drug therapies because of long waiting times to see psychological therapists face to face, despite several guidelines recommending that psychological treatments should be first-line interventions for mild to moderate depression.ObjectiveWe aimed to evaluate, among patients on a waitlist to receive secondary mental health care services for depression, how effective coach-guided web-based therapy (The Journal) is, compared with an information-only waitlist control group, in reducing depression symptoms after 12 weeks.MethodsWe conducted a randomized controlled trial with 2 parallel arms and a process evaluation, which included interviews with study participants. Participants assigned to the intervention group received 12 weeks of web-based therapy guided by a coach who had a background in social work. Patients in the control group receive a leaflet of mental health resources they could access. The primary outcome measure was a change in depression scores, as measured by the Patient-Health Questionnaire (PHQ-9).ResultsA total of 95 participants were enrolled (intervention, n=47; control, n=48). The mean change in PHQ-9 scores from baseline to week 12 was −3.6 (SD 6.6) in the intervention group and −3.1 (SD 6.2) in the control group, which was not a statistically significant difference with a two-sided alpha of .05 (t91=−0.37; P=.72, 95% CI −3.1 to 2.2). At 12 weeks, participants in the intervention group reported higher health-related quality of life (mean EuroQol 5 dimensions visual analogue scale [EQ-5D-VAS] score 66.8, SD 18.0) compared with the control group (mean EQ-5D VAS score 55.9, SD 19.2; t84=−2.73; P=.01). There were no statistically significant differences between the two groups in health service use following their initial consultation with a psychiatrist. The process evaluation showed that participants in the intervention group completed a mean of 5.0 (SD 2.3) lessons in The Journal and 8.8 (SD 3.1) sessions with the coach. Most participants (29/47, 62%) in the intervention group who completed the full dose of the intervention, by finishing 6 or more lessons in The Journal, were more likely to have a clinically important reduction in depressive symptoms at 12 weeks compared with the control group (Χ21=6.3; P=.01, Φ=0.37). Participants who completed the interviews reported that the role played by the coach was a major factor in adherence to the study intervention.ConclusionsThe results demonstrate that the use of guided web-based therapy for the treatment of depression is not more effective than information-only waitlist control. However, it showed that the coach has the potential to increase adherence and engagement with web-based depression treatment protocols. Further research is needed on what makes the coach effective.Trial RegistrationClinicalTrials.gov: NCT02423733; https://clinicaltrials.gov/ct2/show/NCT02423733

Two-Year Outcome after Implantation of a Full Magnetically Levitated Left Ventricular Assist Device: Results from the ELEVATE Registry

Background: The ELEVATE Registry was designed to study long-term outcomes with the Heartmate 3 (HM3), a fully magnetically levitated centrifugal ventricular assist device, in a real-world population following CE-mark approval. Methods: A total of 540 patients implanted in Europe and the Middle East were followed in ELEVATE. Data collection included baseline demographics, survival, adverse events, quality of life (QOL) [EuroQoL-5 Dimensions visual analogue scale (VAS), and 6-minute walk distance (6MWD)]. Full data sets were available of 463 patients receiving the HM3 as primary implant (Primary Implant Cohort). In addition, the Registry Full Cohort included also pump upgrades from another device (19 patients, Pump Exchange Cohort) and patients experiencing an outcome before having the possibility to sign the Informed Consent for which only outcome data were collected (Anonymized Cohort). The two-year outcomes for the Primary Implant and Full Cohort are presented. Findings: Mean age was 55·6 ± 11·7 years (89% male, 48% ischemic cardiomyopathy). Seventy percent of patients were in INTERMACS Profile 1-3 (Profile 1: 9%, 2:22%, 3:39%) and 12·7% were on temporary mechanical circulatory support. Primary Implant Cohort survival was 83% and Full cohort survival 74·5% after two years. In the Primary Implant Cohort, strokes were observed in 9·7%, gastrointestinal bleedings in 9·7%, pump thrombosis in 1·5% and outflow graft twists in 3·5%. HM3 implantation resulted in a sustained improvement of functional capacity (mean 6MWD increase of 180 meters) and QOL (mean score increase of 31 points). Interpretation: ELEVATE demonstrates good long-term survival rates and sustained improvement of functional capacity in a real-world population with the HM3 ventricular assist device. Adverse event rates including pump thrombosis remain low up to two years. Trial Registration: ClinicalTrials.gov Identifier: NCT02497950 Funding Statement: The ELEVATE Registry was funded by Abbott. Declaration of Interests: Daniel Zimpfer: research grant and advisor, Abbott; Finn Gustafsson: consultant, Abbott; Evgenij Potapov: institutional travel grant, consultant and proctor for Abbott; Yuriy Pya: nothing to declare; Jan Schmitto: consultant and research grant, Abbott; Michael Berchtold-Herz: travel grants, Abbott; Michiel Morshuis: nothing to declare; Steven Shaw: consultant, Abbott; Diyar Saeed: consultant, Abbott; Jacob Lavee: nothing to declare; Gerald Heatley: Abbott employee; Carlo Gazzola: Abbott employee; Jens Garbade: consultant, Abbott. Ethical Approval Statement: The registry was conducted in accordance with the Declaration of Helsinki and its protocol and informed consent form were approved by each institution’s Ethics Committee.

Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis

BackgroundIxekizumab improves signs/symptoms of psoriatic arthritis (PsA). We present an integrated analysis of baseline disease burden and post-baseline outcomes in ixekizumab-treated patients with enthesitis or dactylitis.MethodsData from SPIRIT-P1 and SPIRIT-P2 were integrated. Patients with PsA were randomized to 80-mg ixekizumab every 4 weeks (IXEQ4W) or 2 weeks (IXEQ2W), after a 160-mg starting dose, or to placebo. Inadequate responders at week 16 received rescue therapy. Among patients with baseline enthesitis (Leeds Enthesitis Index [LEI] > 0) or dactylitis (Leeds Dactylitis Index-Basic [LDI-B] > 0), baseline characteristics and disease burden were reported. At week 24, LEI and LDI-B (percentage of patients with resolution [LEI = 0, LDI-B = 0]) were assessed. In pooled treatment groups, the impact of enthesitis or dactylitis resolution on health-related quality of life (HRQoL) (EuroQol-5 Dimensions Visual Analogue Scale [EQ-5D VAS]), physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]), and pain was assessed.ResultsThe integrated analysis set comprised 679 patients; of these, 60% (n = 403 of 675) had baseline enthesitis (LEI > 0) and 23% (n = 155 of 676) had baseline dactylitis (LDI > 0). At week 24, ixekizumab-treated patients experienced significantly more resolution than placebo of enthesitis (39% IXEQ4W, 35% IXEQ2W, 21% placebo) and dactylitis (78% IXEQ4W, 65% IXEQ2W, 24% placebo). Furthermore, at entheseal points measured by the LEI, ixekizumab-treated patients had significantly higher resolution of enthesitis compared to placebo. At week 24, among all placebo- and ixekizumab-treated patients, resolution of enthesitis was associated with improvements in function and HRQoL whereas dactylitis resolution was associated with more limited improvements. The least squares mean HAQ-DI improvements from baseline were − 0.44 and − 0.25 for patients who did/did not resolve enthesitis, and − 0.41 and − 0.31 for patients who did/did not resolve dactylitis. EQ-5D VAS improvements were 12.3 and 5.8 for patients who did/did not resolve enthesitis, and 10.8 and 9.8 for patients who did/did not resolve dactylitis.ConclusionsAmong patients with pre-existing enthesitis or dactylitis, IXEQ2W- and IXEQ4W-treatment resulted in significant improvements in enthesitis and dactylitis. Enthesitis resolution was associated with improvements in patients’ function, pain, and HRQoL.Trial registrationClinicalTrials.gov, NCT01695239, registered on September 25, 2012, and NCT02349295, registered on October 10, 2014.

Six-month outcomes after treatment of advanced heart failure with a full magnetically levitated continuous flow left ventricular assist device: report from the ELEVATE registry.

The ELEVATE registry was planned to study post-approval outcomes with HeartMate 3™ (HM3), a fully magnetically levitated continuous flow left ventricular assist device (LVAD). A total of 482 patients provided consent to participate in ELEVATE (enrolled cohort). Data collection included baseline demographics, survival, adverse events, quality of life (QOL) [EuroQoL-5 Dimensions visual analogue scale (VAS), and 6-minute walk distance (6MWD)]. An additional 58 patients were implanted with HM3 during the same period but expired or were explanted prior to consent, and only survival data were collected (anonymized cohort). We report the 6-month outcomes of the patients who received HM3 as their primary implant (n = 463) and the survival of the 540 patients in the full cohort (enrolled + anonymized). Baseline characteristics included a mean age of 55.6 ± 11.7 years, 89% male, 48% ischaemic aetiology, and 70% on inotropes. The majority of patients (66%) were bridge-to-transplantation (BTT) and 32% were INTERMACS profile 1-2. Full cohort survival at 6 months was 82 ± 2%. In the enrolled primary implant patients, there was no incidence of pump thrombosis, major bleeding was 25%, major infection 35%, and any stroke type 5%. Functional capacity improved significantly (Δ6MWD 230 ± 191 m) as did QOL (ΔVAS 31 ± 23). Freedom from unplanned rehospitalizations at 6 months was 68 ± 2%. The 6-month outcomes of the HM3 LVAD demonstrate a highly reliable, thrombosis free, device with low incidence of stroke and improved functional capacity, and QOL. NCT02497950.

Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1).

ObjectiveTo report patient-reported outcomes of patients with PsA treated with ixekizumab up to 52 weeks.MethodsIn SPIRIT-P1, biologic-naïve patients with active PsA were randomized to ixekizumab 80 mg every 4 weeks (IXEQ4W; N = 107) or every 2 weeks (IXEQ2W; N = 103) following a 160 mg starting dose, adalimumab 40 mg every 2 weeks (ADA; N = 101) or placebo (PBO; N = 106) during the initial 24-week double-blind treatment period. At week 24 (week 16 for inadequate responders), ADA (8-week washout before starting ixekizumab) and PBO patients were re-randomized to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at week 24 received the same dose during the extension period (EP) to week 52. Patients completed measures including the Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions Visual Analogue Scale and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem.ResultsThe IXEQ4W, IXEQ2W and ADA groups reported significant improvements in DLQI at week 24; 22% (PBO), 53% (IXEQ4W), 63% (IXEQ2W) and 54% (ADA) of patients reported DLQI scores of 0/1. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2 physical component summary and some domain scores, and European Quality of Life 5 Dimensions Visual Analogue Scale at weeks 12 and 24; and in three of four Work Productivity and Activity Impairment Questionnaire-Specific Health Problem domains at week 24. Results are also presented through week 52 for the EP.ConclusionIn biologic-naïve patients with active PsA, ixekizumab significantly improved skin symptoms, health-related quality of life and work productivity.Trial RegistrationClinicalTrials.gov, http://clinicaltrials.gov, NCT01695239; EU Clinical Trials Register, https://www.clinicaltrialsregister.eu, EudraCT2011-002326-49