OP443 Evaluating The Value Of Endovascular Innovations For Aortic Valve Replacement Through Clinical Benefits, Patient-reported Outcomes And Resource Consumption.

2021 ◽  
Vol 37 (S1) ◽  
pp. 17-17
Author(s):  
Eduardo Pinar ◽  
Juan García de Lara ◽  
José Hurtado ◽  
Miguel Robles ◽  
Gunnar Leithold ◽  
...  
Keyword(s):  
High Risk ◽  
Aortic Valve ◽  
Short Form ◽  
Systematic Evaluation ◽  
Special Importance ◽  
Economic Modelling ◽  
Sf 36 ◽  
Patient Reported ◽  
Clinical Benefits ◽  
Sapien 3

IntroductionThe use of most recent Transcatheter aortic valve implants (TAVI) in the treatment of symptomatic severe aortic stenosis (SAS) is evolving with expanded indications from inoperable/high-risk to intermediate and low risk patients. Consequently, TAVI outcomes must be monitored to highlight its value under real-world conditions. Our aim was to prospectively evaluate TAVI (SAPIEN 3) outcomes in terms of patient's health-related quality of life (HRQoL), clinical outcomes, and healthcare resource utilization (HRU).MethodsAn observational prospective study including all consecutive patients with SAS undergoing a transcatheter valve implantation with Edwards SAPIEN 3 valve (transfemoral access) was conducted in full accordance with clinical guidelines from the European Society of Cardiology. Patients were evaluated before the intervention (baseline), at discharge, and after one, six and twelve months from the implant. A thoughtful and systematic evaluation of patients’ HRQoL (EQ-5D 5L, the Short Form-36 Health Survey -SF-36- and the Kansas City Cardiomyopathy Questionnaire -KCCQ-), clinical endpoints (that is, cardiovascular mortality, and rates of stroke, major bleeding, myocardial infarction, and re-hospitalization), echocardiographic measurements, and HRU (that is, Length of stay-LOS- in ward/intensive care unit -ICU-) was implemented. Multivariate regression models were applied to test outcomes while controlling key risk factors (that is, patient’ severity at baseline).ResultsA total of seventy-six patients (fifty percent female, fifty-five percent of intermediate-high risk) with a mean age of 82.1 ± 4.78 years were included. Implant success was 97.34% and cardiovascular death was 2.6% at one year. Significant reductions in mean and maximum gradients were achieved and maintained during follow-up. Mean LOS in ward (5.2 ± 4.0days) and ICU (0.22 ± 0.64 days) were low. Statistically significant improvements were detected in the KCCQ overall summary scores, EQ-5D, and SF-36 (Physical component summary) - all adjusted - p < 0.05 - after the intervention.ConclusionsTAVI represents a safe and effective innovation for SAS with clinical benefits translated into significant improvements in terms of HRQoL. Besides, the low HRU provides new insights for health-economic modelling and the optimization of limited resources of special importance under current pandemic situation.

Assessment of computer adaptive testing version of the Neuro-QOL for people with multiple sclerosis

2018 ◽  
Vol 25 (13) ◽  
pp. 1791-1799 ◽  
Author(s):  
Brian C Healy ◽  
Jonathan Zurawski ◽  
Cindy T Gonzalez ◽  
Tanuja Chitnis ◽  
Howard L Weiner ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Outcome Measures ◽  
Computerized Adaptive Testing ◽  
Short Form ◽  
Patient Reported Outcome Measures ◽  
Adaptive Testing ◽  
Patient Reported Outcome ◽  
Longitudinal Change ◽  
Sf 36 ◽  
Patient Reported

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.

scholarly journals Patient-Reported Outcomes and Patient-Reported Satisfaction After Surgical Treatment for Cervical Radiculopathy

2018 ◽  
Vol 8 (7) ◽  
pp. 703-708 ◽  
Author(s):  
Andreas Kiilerich Andresen ◽  
Rune Tendal Paulsen ◽  
Frederik Busch ◽  
Alexander Isenberg-Jørgensen ◽  
Leah Y. Carreon ◽  
...  
Keyword(s):  
Short Form ◽  
Neck Disability Index ◽  
Visual Analogue Score ◽  
Cervical Radiculopathy ◽  
Strongly Correlated ◽  
Anterior Cervical Decompression ◽  
Sf 36 ◽  
Patient Reported ◽  
Neck Disability ◽  
Cervical Degenerative Disease

Study Design: Retrospective cohort study. Objectives: It is estimated that 10 000 patients seek medical care due to cervical radiculopathy every year in Denmark. Although the natural course is usually favorable, around 20% undergo surgery for cervical degenerative disease every year in Denmark. We aim to evaluate the patient-reported results and satisfaction of anterior cervical decompression and fusion over a 5-year period from a single Danish center for spine surgery. Methods: This study is a retrospective study based on prospectively collected data from 318 consecutive patients treated with anterior cervical decompression and fusion over 1 to 3 levels. Data in the DaneSpine registry was collected pre- and postoperatively, and at 1 year after surgery. The outcome measures were Neck Disability Index (NDI), European Quality of Life 5D (EQ-5D), visual analogue score (VAS), and Short Form-36 Physical Component Summary (SF-36 PCS). Results: Of 318 cases enrolled, 272 (85.5%) had follow-up data available at a minimum 1-year postoperatively. The mean preoperative NDI was 40.0 and improved to 22.7. Mean EQ-5D was 0.50 and improved to 0.70, and mean VAS arm was 60.4 improved to 26.4. All improvements were statistically significant. A total of 74.3% were back to work 1 year after surgery. Achieving minimal clinically important difference (MCID) in VAS neck and SF-36 PCS was strongly correlated to patient satisfaction. Conclusion: Patients who undergo anterior cervical discectomy and fusion can expect improvement in their pain and disability, with 74.3% of patients reporting a positive change in health status after surgery.

PATIENT-REPORTED OUTCOMES AND DISABILITY IN MULTIPLE SCLEROSIS

2015 ◽  
Vol 86 (11) ◽  
pp. e4.32-e4
Author(s):  
Neil Scolding ◽  
Hongwei Wang ◽  
Yan Liu ◽  
Lawrence Steinman
Keyword(s):  
Multiple Sclerosis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Minimum Important Difference ◽  
Point Change ◽  
Clinical Difference ◽  
Sf 36 ◽  
Patient Reported ◽  
Edss Score ◽  
Multiple Sclerosis Patients

In the 2-year, phase 3 CARE-MS II study (NCT00548405), alemtuzumab demonstrated superior clinical and patient-reported outcomes (PROs) over subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis patients who had inadequate efficacy response to prior therapy. To further evaluate the relationship between PROs and disability, Short-Form 36-Item (SF-36) survey physical component summary (PCS) and mental component summary (MCS), and Functional Assessment of Multiple Sclerosis (FAMS) scores were analysed against Expanded Disability Status Scale (EDSS) outcomes, adjusted for baseline characteristics and randomisation arm. A 1.0-point difference in baseline EDSS score was associated with 2.0-point PCS, 0.8-point MCS, and 4.0-point FAMS worsening over 12 months (all P<0.001). A 1.0-point annualised EDSS score worsening corresponded to a 2.2-point PCS, 1.6-point MCS, and 6.0-point FAMS worsening (all P<0.001). For baseline EDSS score <4.0, 1.0-point annualised worsening was associated with 7.2-point FAMS and 2.0-point MCS worsening (both P<0.001). For baseline EDSS score ≥4.0, 1.0-point worsening corresponded to worsening on FAMS (2.4 points; P=0.04), but not MCS (P=0.82). Given that a half-point EDSS change is considered the minimum reliably measurable clinical difference, a 1.0-point change in SF-36 PCS and MCS or 3.0-point change in FAMS may represent a minimum important difference in PRO for multiple sclerosis patients.

scholarly journals The German Version of the Veterans Rand – 36/12 Item Health Survey: Translation and Adaptation of a Generic Health Assessment Instrument in a Sample of Inpatient Rehabilitation Patients

2020 ◽  
Author(s):  
Ines Buchholz ◽  
You-Shan Feng ◽  
Maresa Buchholz ◽  
Lewis E. Kazis ◽  
Thomas Kohlmann
Keyword(s):  
Health Survey ◽  
Short Form ◽  
Inpatient Rehabilitation ◽  
Assessment Instrument ◽  
Self Report ◽  
German Version ◽  
Distributional Properties ◽  
Sf 36 ◽  
Patient Reported ◽  
Normally Distributed

Abstract BackgroundThe translated and culturally adapted German version of the Veterans Rand 36 Items Health Survey (VR-36), and its short form, the VR-12 counterpart, were validated in a German sample of orthopedic (n = 399) and psychosomatic (n = 292) inpatient rehabilitation patients.MethodsThe instruments were analyzed regarding their acceptance, distributional properties, validity, responsiveness and ability to discriminate between groups by age, sex and clinically specific groups. Eligible study participants completed the VR-36 (n = 169) and the VR-12 (n = 177). They also completed validated patient-reported outcome measures (PROs) including the Euroqol-5 Dimensions 5 Level (EQ-5D-5L); Depression, Anxiety and Stress Scale (DASS); Hannover Functional Abilities Questionnaire (HFAQ); and CDC Healthy Days. The VR-12 and the VR-36 were compared to the reference instruments MOS Short Form-12 Items Health Survey (SF-12) version 1.0 and MOS Short Form-36 Items Health Survey (SF-36) version 1.0, using percent of completed items, distributional properties, correlation patterns, distribution measures of known groups validity, confirmatory factor analysis (CFA) and effect size measures.ResultsItem non-response varied between 1.8%/1.1% (SFVR−36/RESF−36) and 6.5%/8.6% (GHVR−36/GHSF−36). PCS was normally distributed (Kolmogorov-Smirnov Tests: p > 0.05) with means, standard deviations and ranges very similar between SF-36 (37.5 ± 11.7[13.8–66.1]) and VR-36 (38.5 ± 10.1[11.7–67.8]), SF-12 (36.9 ± 10.9[15.5–61.6]) and VR-12 (36.2 ± 11.5[12.7–59.3]). MCS was not normally distributed with slightly differing means and ranges between the instruments (MCSVR−36: 36.2 ± 14.2[12.9–66.6], MCSSF−36: 39.0 ± 15.6[2.0-73.2], MCSVR−12: 37.2 ± 13.8[8.4–70.2], MCSSF−12: 39.0 ± 12.3[17.6–65.4]). Construct validity was established by comparing correlation patterns of the MCSVR and PCSVR with measures of physical and mental health. For both PCSVR and MCSVR there were moderate (0.4–0.7) to high (> 0.7) correlations with convergent (PCSVR: 0.55–0.76, MCSVR: 0.60–0.78) and small correlations (< 0.3) with divergence (PCSVR: <0.12, MCSVR: <0.16) self-report measures. Known-groups validity was demonstrated for both VR-12 and VR-36 (MCS and PCS) via comparisons of distribution parameters with significant higher mean PCS and MCS scores in both VR instruments found in younger patients with fewer sick days in the last year and a shorter duration of rehabilitation.ConclusionsThe psychometric analysis confirmed that the German VR is a valid and reliable instrument for use in orthopedic and psychosomatic rehabilitation. Yet further research is needed to evaluate its usefulness in other populations.

scholarly journals Numerical models for assessing the risk of leaflet thrombosis post-transcatheter aortic valve-in-valve implantation

2020 ◽  
Vol 7 (12) ◽  
pp. 201838
Author(s):  
Romina Plitman Mayo ◽  
Halit Yaakobovich ◽  
Ariel Finkelstein ◽  
Shawn C. Shadden ◽  
Gil Marom
Keyword(s):  
High Risk ◽  
Aortic Valve ◽  
Numerical Models ◽  
Aortic Valves ◽  
Transcatheter Aortic Valve ◽  
Edwards Sapien ◽  
Valve In Valve ◽  
Sapien 3 ◽  
Valve Implantation ◽  
Numerical Approaches

Leaflet thrombosis has been suggested as the reason for the reduced leaflet motion in cases of hypoattenuated leaflet thickening of bioprosthetic aortic valves. This work aimed to estimate the risk of leaflet thrombosis in two post-valve-in-valve (ViV) configurations, using five different numerical approaches. Realistic ViV configurations were calculated by modelling the deployments of the latest version of transcatheter aortic valve devices (Medtronic Evolut PRO, Edwards SAPIEN 3) in the surgical Sorin Mitroflow. Computational fluid dynamics simulations of blood flow followed the dry models. Lagrangian and Eulerian measures of near-wall stagnation were implemented by particle and concentration tracking, respectively, to estimate the thrombogenicity and to predict the risk locations. Most of the numerical approaches indicate a higher leaflet thrombosis risk in the Edwards SAPIEN 3 device because of its intra-annular implantation. The Eulerian approaches estimated high-risk locations in agreement with the wall sheer stress (WSS) separation points. On the other hand, the Lagrangian approaches predicted high-risk locations at the proximal regions of the leaflets matching the low WSS magnitude regions of both transcatheter aortic valve implantation models and reported clinical and experimental data. The proposed methods can help optimizing future designs of transcatheter aortic valves with minimal thrombotic risks.

scholarly journals Perceived functioning, well-being and psychiatric symptoms in patients with stable schizophrenia treated with long-acting risperidone for 1 year

2005 ◽  
Vol 187 (2) ◽  
pp. 131-136 ◽  
Author(s):  
W. Wolfgang Fleischhacker ◽  
Jonathan Rabinowitz ◽  
Georg Kemmler ◽  
Mariëlle Eerdekens ◽  
Angelika Mehnert
Keyword(s):  
Mental Component Summary ◽  
Psychiatric Symptoms ◽  
Short Form ◽  
Mental Component Summary Score ◽  
Well Being ◽  
Psychotic Symptoms ◽  
Open Label ◽  
Sf 36 ◽  
Patient Reported ◽  
Long Acting

BackgroundThe extent to which antipsychotics improve patients' well-being is uncertain.AimsTo examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone.MethodIn a 1-year, open-label, international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia, self-rated functioning and well-being were measured every 3 months using the Short Form 36-item questionnaire (SF–36). Psychopathology was quantified using the Positive and Negative Syndrome Scale (PANSS).ResultsSignificant improvements were found on the SF–36 mental component summary score and vitality and social functioning scales. PANSS and mental component summary scores were moderately correlated.ConclusionsPatient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms. Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes.

scholarly journals Effect of Psychotropic Medications on Hammertoe Reconstruction Outcomes

2020 ◽  
Vol 5 (3) ◽  
pp. 247301142094413
Author(s):  
Samuel D. Maidman ◽  
Amalie E. Nash ◽  
Amanda Fantry ◽  
Shay Tenenbaum ◽  
Yahya Daoud ◽  
...  
Keyword(s):  
Short Form ◽  
Medication Use ◽  
Psychotropic Medications ◽  
Activity Level ◽  
Mood Stabilizers ◽  
Level Of Evidence ◽  
Sf 36 ◽  
Significant Difference ◽  
Patient Reported ◽  
Before And After

Background: Hammertoe deformities can seriously affect activity level and footwear. The use of prescription, mood-altering medications is very common, with some estimates as high as 25% of the population. Mood disorders, especially depression, negatively affect the results of medical and operative treatments. This study assessed the relationship of mood-altering medication use with the outcomes and complications of operative reconstruction of hammertoes. Methods: Data were prospectively collected from 116 patients who underwent hammertoe reconstruction, including demographic information, medical history, the use of mood-altering psychotropic medications (antidepressants, anxiolytics, hypnotics, and mood stabilizers), and postoperative complications. Preoperative patient-reported outcomes were measured using the visual analog scale (VAS) for pain and Short Form Health Survey (SF-36), which were repeated at 1-year follow-up. Results: A total of 36.2% of patients were taking psychotropic medications. Medication and nonmedication groups had similar pain VAS and SF-36 Physical Component Summary (PCS) scores before and after surgery. Compared with nonmedication patients, patients on psychotropic medications had significantly lower SF-36 Mental Component Summary (MCS) scores preoperatively ( P = .001) and postoperatively ( P = .006), but no significant difference in the change in MCS (ΔMCS) from preoperative to postoperative. Psychotropic medication use was associated with superficial wound infections ( P = .048), but not other complications. Conclusions: Patients taking psychotropic medications were equally likely to benefit from forefoot reconstruction as nonmedication patients. Preoperative and postoperative PCS and VAS were not significantly different between medication and nonmedication groups. Although the medication group had lower absolute MCS, they reported the same magnitude of improvement in MCS (ΔMCS) as the nonmedication group. Level of Evidence: Level II, prospective cohort study.

Outcomes of Total Ankle Arthroplasty in Moderate and Severe Valgus Deformity

2018 ◽  
Vol 12 (3) ◽  
pp. 238-245 ◽  
Author(s):  
Constantine A. Demetracopoulos ◽  
Elizabeth A. Cody ◽  
Samuel B. Adams ◽  
James K. DeOrio ◽  
James A. Nunley ◽  
...  
Keyword(s):  
Short Form ◽  
Valgus Deformity ◽  
Total Ankle Arthroplasty ◽  
Ankle Arthroplasty ◽  
Short Musculoskeletal Function Assessment ◽  
Sf 36 ◽  
Patient Reported ◽  
Musculoskeletal Function ◽  
American Orthopaedic

Introduction. Failure to correct coronal deformity at the time of total ankle arthroplasty (TAA) can lead to early implant failure. We aimed to determine clinical, radiographic, and patient-reported outcomes of patients with moderate to severe valgus deformity who underwent TAA for end-stage ankle arthritis. Methods. Patients with a valgus deformity of at least 10° who underwent TAA were retrospectively reviewed. The coronal tibiotalar angle was assessed on radiographs preoperatively, at 1 year, and at final follow-up. The visual analog scale (VAS) for pain, Short Form-36 (SF-36), American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot-ankle scale, and Short Musculoskeletal Function Assessment (SMFA) scores were assessed preoperatively and at final follow-up. Results. Mean preoperative valgus deformity was 15.5 ± 5.0°, and was corrected to a mean of 1.2 ± 2.6° of valgus postoperatively. VAS, SF-36, AOFAS, and SMFA scores improved significantly ( P < .001 for all). There was no significant change in tibiotalar angle between 1 year and final follow-up in either group. Reoperation and revision rates did not differ between groups. Conclusion. Correction of coronal alignment was achieved and maintained in patients with both moderate and severe preoperative valgus malalignment. Outcome scores significantly improved for all patients. Levels of Evidence: Therapeutic, Level IV

scholarly journals Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial

RMD Open ◽  
2019 ◽  
Vol 5 (2) ◽  
pp. e001040 ◽  
Author(s):  
Vibeke Strand ◽  
Eduardo Mysler ◽  
Robert J Moots ◽  
Gene V Wallenstein ◽  
Ryan DeMasi ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Controlled Trial ◽  
Inadequate Response ◽  
Link Type ◽  
Combination Treatments ◽  
Sf 36 ◽  
Patient Reported ◽  
Phase Iiib

ObjectiveTo provide the first direct comparison of patient-reported outcomes (PROs) following treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate response to MTX (MTX-IR).MethodsORAL Strategy (NCT02187055), a phase IIIB/IV, head-to-head, randomised controlled trial, assessed non-inferiority between tofacitinib 5 mg two times per day monotherapy, tofacitinib 5 mg two times per day+MTX and ADA 40 mg every other week+MTX. PROs assessed included the following: Patient Global Assessment of disease activity (PtGA), Pain, Health Assessment Questionnaire-Disability Index, Functional Assessment of Chronic Illness Therapy-Fatigue and 36-Item Short-Form Health Survey (SF-36) summary and domain scores.ResultsSubstantial improvements from baseline were reported across all PROs in all treatment arms, which, in the majority, met or exceeded minimum clinically important differences. Compared with tofacitinib monotherapy, tofacitinib+MTX combination treatment conferred significantly greater improvements in PtGA, Pain and SF-36 physical component summary scores at month 6. Statistically or numerically greater improvements were often, but not uniformly, reported for combination treatments compared with tofacitinib monotherapy at other time points.ConclusionTreatment with tofacitinib+MTX, ADA+MTX and tofacitinib monotherapy resulted in clinically meaningful improvements in PROs in MTX-IR patients with RA. These were comparatively greater with combination treatments versus tofacitinib monotherapy, although differences between treatment arms were small, limiting our ability to confer clinical meaning.Trial registration numberNCT02187055.

Validity of the PROMIS-29 in a large Australian cohort of patients with systemic sclerosis

2017 ◽  
Vol 2 (3) ◽  
pp. 188-195 ◽  
Author(s):  
Kathleen Morrisroe ◽  
Wendy Stevens ◽  
Molla Huq ◽  
Joanne Sahhar ◽  
Gene-Siew Ngian ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systemic Sclerosis ◽  
Construct Validity ◽  
Short Form ◽  
Good Alternative ◽  
Measurement Information ◽  
Internal Reliability ◽  
Sf 36 ◽  
Patient Reported

Background We aimed to evaluate the construct validity of the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) in Australian systemic sclerosis (SSc) patients. Methods SSc patients, identified through the Australian Scleroderma Cohort Study database, completed two quality-of-life instruments concurrently, the PROMIS-29 and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). The construct validity of the PROMIS-29 was assessed by the correlations between the PROMIS-29 and the SF-36 and Health Assessment Questionnaire Disability Index (HAQ-DI). Cronbach's alpha was used to test the internal reliability of all instruments in Australian SSc patients and non-parametric correlation, including Spearman's correlation, was used to test the construct validity of PROMIS-29 against the SF-36 and HAQ-DI. Results A total of 477 completed questionnaires were returned, equating to a response rate of 59.6%. The mean (±SD) age of respondents at the time of the survey was 64.1 (±11.1) years. They were predominantly female (87.4%), with limited disease subtype (lcSSc) (77.8%) and long disease duration from onset of first non-Raynaud's phenomenon symptom at the time of survey (10.9 ± 11.1 years). For the correlation analysis between the PROMIS-29 and the legacy instruments, all Spearman correlation coefficients were in the logical direction and highly significant suggesting that the PROMIS-29 is a good alternative to other validated measures of disease burden. Conclusions Our study indicates that the PROMIS-29 questionnaire is a valid instrument for measuring health-related quality of life in Australian females with lcSSc of long duration.

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