1516P Core variables for managed entry agreements, regarding clinical outcomes and patient reported measures, in cancer

2021 ◽  
Vol 32 ◽  
pp. S1108
Author(s):  
A. Silva ◽  
F.R. Gonçalves
Keyword(s):  
Clinical Outcomes ◽  
Patient Reported ◽  
Managed Entry Agreements ◽  
Patient Reported Measures

scholarly journals RADT-47. A MULTICENTER OBSERVATIONAL STUDY OF SURGICALLY TARGETED RADIATION THERAPY (START) USING IMPLANTED CS-131 SEEDS IN A COLLAGEN-BASED CARRIER TILE IN INTRACRANIAL BRAIN NEOPLASMS - PROTOCOL IN PROGRESS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii191-ii192
Author(s):  
Peter Nakaji ◽  
David Brachman ◽  
Lisa Misell
Keyword(s):  
Radiation Therapy ◽  
Brain Tumors ◽  
Clinical Outcomes ◽  
Local Control ◽  
Real World ◽  
Functional Decline ◽  
Registry Study ◽  
Multicenter Observational Study ◽  
Patient Reported ◽  
Targeted Radiation Therapy

Abstract INTRODUCTION Post-resection radiotherapy (RT) is the most effective adjuvant treatment for brain tumors. However, there is no current consensus as to the “best” type of post-resection RT, either at diagnosis or recurrence. The use of internally placed radiation (brachytherapy) allows immediate initiation of RT when residual tumor burden is minimal, which theoretically should lessen the risk of recurrence. Brachytherapy placement intraoperatively allows more precise identification of the tumor margins than by postoperative imaging. Traditional brachytherapy methods have several drawbacks, including uneven dose distribution, long operating room times, a need for expensive equipment, and/or frequent adverse events (AE). To address these issues, a device with Cs-131 radiation seeds in a resorbable collagen-based carrier tile (GammaTile, GT Medical Technologies, Tempe AZ) was developed and is described as Surgically Targeted Radiation Therapy or STaRT. The device has demonstrated excellent safety and local control in early commercial use. OBJECTIVE The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT. METHOD Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Accrual to start at 20+ sites in Q3 2020. Data collected includes local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE’s. Data will be collected at 1, 3, 6, 9, and 12 months, then every 6 months through 5 years. RESULT Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. CONCLUSION This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

scholarly journals SYMPERHEART: an intervention to support symptom perception in persons with heart failure and their informal caregiver: a feasibility quasi-experimental study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e052208
Author(s):  
Gabrielle Cécile Santos ◽  
Maria Liljeroos ◽  
Roger Hullin ◽  
Kris Denhaerynck ◽  
Justine Wicht ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Outcomes ◽  
Informal Caregiver ◽  
Informal Caregivers ◽  
Self Care ◽  
Symptom Perception ◽  
Convenience Sample ◽  
Failure Index ◽  
Patient Reported ◽  
Quasi Experimental

IntroductionSymptom perception in heart failure (HF) has been identified as crucial for effective self-care, and is related to patient and health system outcomes. There is uncertainty regarding the feasibility and acceptability of symptom perception support and doubts regarding how to include informal caregivers. This study aims to test the feasibility, acceptability and outcome responsiveness of an intervention supporting symptom perception in persons with HF and their informal caregiver.Methods and analysisA feasibility study with a quasi-experimental pretest and post-test single group design is conducted. The convenience sample consists of 30 persons with HF, their informal caregivers and six nurses. SYMPERHEART is an evidence-informed intervention that targets symptom perception by educational and support components. Feasibility is measured by time-to-recruit; time-to-deliver; eligibility rate; intervention delivery fidelity rate. Acceptability is measured by rate of consent, retention rate, treatment acceptability and the engagement in the intervention components. Outcome responsiveness includes: HF self-care (via the Self-care of Heart Failure Index V.7.2); perception of HF symptom burden (via the Heart Failure Somatic Perception Scale V.3); health status (via the Kansas City Cardiomyopathy Questionnaire-12); caregivers’ contribution to HF self-care (via the Caregiver Contribution to Self-Care of Heart Failure Index 2); caregivers’ burden (via the Zarit Burden Interview). Clinical outcomes include HF events, hospitalisation reason and length of hospital stay. Descriptive statistics will be used to report feasibility, acceptability, patient-reported outcomes (PRO) and clinical outcomes. PRO and caregiver-reported outcome responsiveness will be reported with mean absolute change and effect sizes.Ethics and disseminationThe study is conducted according to the Declaration of Helsinki. The Human Research Ethics Committee of the Canton of Vaud, Switzerland, has approved the study. Written informed consent from persons with HF and informal caregivers are obtained. Results will be published via peer reviewed and professional journals, and further disseminated via congresses.Trial registration numberISRCTN18151041.

scholarly journals In vitro responses to platelet-rich-plasma are associated with variable clinical outcomes in patients with knee osteoarthritis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Habib Zahir ◽  
Bijan Dehghani ◽  
Xiaoning Yuan ◽  
Yurii Chinenov ◽  
Christine Kim ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Clinical Outcomes ◽  
Inflammatory Responses ◽  
Platelet Rich Plasma ◽  
Autologous Blood ◽  
Limited Information ◽  
Knee Oa ◽  
Patient Reported ◽  
Treatment Comparisons

AbstractAutologous blood-derived products such as platelet-rich plasma (PRP) are widely used to treat musculoskeletal conditions, including knee osteoarthritis (OA). However, the clinical outcomes after PRP administration are often variable, and there is limited information about the specific characteristics of PRP that impact bioactivity and clinical responses. In this study, we aimed to develop an integrative workflow to evaluate responses to PRP in vitro, and to assess if the in vitro responses to PRP are associated with the PRP composition and clinical outcomes in patients with knee OA. To do this, we used a coculture system of macrophages and fibroblasts paired with transcriptomic analyses to comprehensively characterize the modulation of inflammatory responses by PRP in vitro. Relying on patient-reported outcomes and achievement of minimal clinically important differences in OA patients receiving PRP injections, we identified responders and non-responders to the treatment. Comparisons of PRP from these patient groups allowed us to identify differences in the composition and in vitro activity of PRP. We believe that our integrative workflow may enable the development of targeted approaches that rely on PRP and other orthobiologics to treat musculoskeletal pathologies.

scholarly journals Outcomes of Arthroscopic Capsular Release in the Beach-Chair Versus Lateral Decubitus Position: A Systematic Review

2019 ◽  
Vol 7 (12) ◽  
pp. 232596711988817 ◽  
Author(s):  
Darby A. Houck ◽  
John W. Belk ◽  
Armando F. Vidal ◽  
Eric C. McCarty ◽  
Jonathan T. Bravman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Outcomes ◽  
Cochrane Library ◽  
Recurrence Rates ◽  
Capsular Release ◽  
Arthroscopic Capsular Release ◽  
Patient Reported ◽  
Lateral Decubitus ◽  
Beach Chair

Background: Arthroscopic capsular release (ACR) for the treatment of adhesive capsulitis of the shoulder can be performed in either the beach-chair (BC) or lateral decubitus (LD) position. Purpose: To determine the clinical outcomes and recurrence rates after ACR in the BC versus LD position. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines was performed by searching PubMed, Embase, and the Cochrane Library databases for studies reporting clinical outcomes of patients undergoing ACR in either the BC or LD position. All English-language literature from 1990 through 2017 reporting on clinical outcomes after ACR with a minimum 3-month follow-up were reviewed by 2 independent reviewers. Recurrence rates, range of motion (ROM) results, and patient-reported outcome (PRO) scores were collected. Study methodological quality was evaluated using the modified Coleman Methodology Score (MCMS). Results: A total of 30 studies (3 level 1 evidence, 2 level 2 evidence, 4 level 3 evidence, 21 level 4 evidence) including 665 shoulders undergoing ACR in the BC position (38.1% male; mean age, 52.0 ± 3.9 years; mean follow-up, 35.4 ± 18.4 months) and 603 shoulders in the LD position (41.8% male; mean age, 53.0 ± 2.3 years; mean follow-up, 37.2 ± 16.8 months) were included. There were no significant differences in overall mean recurrence rates between groups (BC, 2.5%; LD, 2.4%; P = .81) or in any PRO scores between groups ( P > .05). There were no significant differences in improvement in ROM between groups, including external rotation at the side (BC, 36.4°; LD, 42.8°; P = .91), forward flexion (BC, 64.4°; LD, 79.3°; P = .73), abduction (BC, 77.8°; LD, 81.5°; P = .82), or internal rotation in 90° of abduction (BC, 40.8°; LD, 45.5°; P = .70). Significantly more patients in the BC group (91.6%) underwent concomitant manipulation than in the LD group (63%) ( P < .0001). There were significantly more patients with diabetes in the LD group (22.4%) versus the BC group (9.6%) ( P < .0001). Conclusion: Low rates of recurrent shoulder stiffness and excellent improvements in ROM can be achieved after ACR in either the LD or BC position. Concomitant manipulation under anesthesia is performed more frequently in the BC position compared with the LD position.

scholarly journals Ambulatory Neuroproprioceptive Facilitation and Inhibition Physical Therapy Improves Clinical Outcomes in Multiple Sclerosis and Modulates Serum Level of Neuroactive Steroids: A Two-Arm Parallel-Group Exploratory Trial

Life ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. 267
Author(s):  
Gabriela Angelova ◽  
Tereza Skodova ◽  
Terezie Prokopiusova ◽  
Magdalena Markova ◽  
Natalia Hruskova ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Physical Therapy ◽  
Serum Level ◽  
Clinical Outcomes ◽  
Endocrine System ◽  
Motor Program ◽  
Neuroactive Steroids ◽  
Patient Reported ◽  
Serial Addition ◽  
Post Assessment

Background: Only few studies have monitored the potential of physical activity training and physical therapy to modulate the reaction of the endocrine system. In this study, the effect of neuroproprioceptive facilitation and inhibition physical therapy on clinical outcomes and neuroactive steroids production in people with multiple sclerosis was evaluated. Moreover, we were interested in the factors that influence the treatment effect. Methods: In total, 44 patients with multiple sclerosis were randomly divided into two groups. Each group underwent a different kind of two months ambulatory therapy (Motor program activating therapy and Vojta’s reflex locomotion). During the following two months, participants were asked to continue the autotherapy. Primary (serum level of cortisol, cortisone, 7α-OH-DHEA, 7β-OH-DHEA, 7-oxo-DHEA, DHEA) and secondary (balance, cognition and patient-reported outcomes) outcomes were examined three times (pre, post, and washout assessments). Results: In both groups, there is a decreasing trend of 7-oxo-DHEA concentration in post-assessment and 7β-OH-DHEA in washout versus pre-assessment. A higher impact on neuroactive steroids is visible after Vojta’s reflex locomotion. As for clinical outcomes, the Paced Auditory Serial Addition Test and Multiple Sclerosis Impact Scale significantly improved between post-assessment and washout assessment. The improvement was similar for both treatments. Conclusions: Neuroproprioceptive facilitation and inhibition improved the clinical outcomes and led to non-significant changes in neuroactive steroids. Trial registration (NCT04379193).

scholarly journals Reoperations Following Lumbar Discectomy Are Associated With Worse Clinical Outcomes and Greater Socioeconomic Burden 3 Years After the Primary Procedure

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Claudius Thomé ◽  
Ali Araghi ◽  
Jason Inzana ◽  
Jonathan Stieber ◽  
Joshua M Ammerman
Keyword(s):  
Back Pain ◽  
Clinical Outcomes ◽  
Lumbar Discectomy ◽  
Control Treatment ◽  
Control Group ◽  
Closure Device ◽  
Number Of Patients ◽  
Patient Reported ◽  
Socioeconomic Burden ◽  
Index Level

Abstract INTRODUCTION Lumbar discectomy patients with large annular defects are at significantly greater risk for symptom recurrence and revision. Previous studies suggest that outcomes following revision surgery are less positive than outcomes from primary discectomy. This analysis aimed to assess the clinical and socioeconomic outcomes associated with postdiscectomy reoperations and the utility of a bone-anchored annular closure device (ACD) for avoiding reoperations. METHODS This study was a retrospective analysis of a prospective randomized controlled trial (RCT). Lumbar discectomy patients with large (>6 mm) annular defects were treated with discectomy alone (Control; n = 278) or discectomy with an ACD (n = 272). Patient-reported outcomes included visual analog scale (VAS) for ipsilateral leg or back pain and Oswestry Disability Index (ODI). At 3 yr, clinical outcomes were available for 75% of the patients. Comparisons of outcomes were made between reoperated (n = 64) and nonreoperated (n = 351) patients, regardless of ACD or Control treatment, at 3 yr following the primary surgery. RESULTS Reoperated patients had significantly worse scores for ODI (24 ± 19 vs 11 ± 13; P < .0001), VAS leg pain (28 ± 30 vs 12 ± 19; P < .0001), and VAS back pain (36 ± 31 vs 17 ± 21; P < .0001). Significantly more nonreoperated patients were working at 3 yr (97% vs 84%; P < .001). Based on Kaplan-Meier analysis, the proportion of subjects experiencing at least 1 index-level reoperation in 3 yr was 11% in the ACD group and 19% in the Control group (P = .007). CONCLUSION Index-level reoperations following lumbar discectomy are associated with worse outcomes and greater socioeconomic burden in patients with large annular defects (>6 mm). These findings are consistent with reports from large registry analyses, including the Spine Patient Outcomes Research Trial (SPORT) and the Swedish National Spine Registry (Swespine). The ACD reduced the number of patients experiencing index-level reoperation by 43%.

scholarly journals Relationship Between Patient-Reported Outcomes and Clinical Outcomes in Patients With Morquio A Syndrome

2015 ◽  
Vol 3 ◽  
pp. 232640981557618 ◽  
Author(s):  
Christina Lampe ◽  
Mohit Jain ◽  
Andrew Olaye ◽  
Bianca Meesen ◽  
Celeste Decker ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Patient Reported Outcomes ◽  
Morquio A ◽  
Patient Reported ◽  
Morquio A Syndrome

scholarly journals Patient-Reported Outcome Measures and Clinical Outcomes in Children with Foregut Anomalies

Children ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 587
Author(s):  
Isabel I. Sreeram ◽  
Chantal A. ten Kate ◽  
Joost van Rosmalen ◽  
Johannes M. Schnater ◽  
Saskia J. Gischler ◽  
...  
Keyword(s):  
Linear Regression ◽  
Clinical Outcomes ◽  
Outcome Measures ◽  
Clinical Decision Making ◽  
Linear Regression Analysis ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Added Value ◽  
Patient Reported

Increasing numbers of children and adults with chronic disease status highlight the need for a value-based healthcare system. Patient-reported outcome measures (PROMs) are essential to value-based healthcare, yet it remains unclear how they relate to clinical outcomes such as health and daily functioning. We aimed to assess the added value of self-reported PROMs for health status (HS) and quality of life (QoL) in the long-term follow-up of children with foregut anomalies. We evaluated data of PROMs for HS and/or QoL among eight-year-olds born with congenital diaphragmatic hernia (CDH), esophageal atresia (EA), or congenital lung malformations (CLM), collected within the infrastructure of a multidisciplinary, longitudinal follow-up program. Clinical outcomes were categorized into different outcome domains, and their relationships with self-reported HS and QoL were assessed through multivariable linear regression analyses. A total of 220 children completed HS and/or QoL self-reports. In children with CDH and EA, lower cognition was significantly associated with lower self-reported HS. Due to the low number of cases, multivariable linear regression analysis was not possible in children with CLM. HS, QoL, and clinical outcomes represent different aspects of a child’s wellbeing and should be measured simultaneously to facilitate a more holistic approach to clinical decision making.

CTNI-59. A MULTICENTER OBSERVATIONAL STUDY OF CS-131 SEEDS EMBEDDED IN A COLLAGEN CARRIER TILE FOR NEWLY DIAGNOSED AND RECURRENT OPERABLE INTRACRANIAL NEOPLASMS – TRIAL IN PROGRESS

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi74-vi74
Author(s):  
Erin Dunbar ◽  
David McCracken ◽  
adam nowlan ◽  
Clark Chen ◽  
Kathryn Dusenbery ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
Real World ◽  
External Beam Radiation ◽  
Newly Diagnosed ◽  
Intracranial Neoplasms ◽  
Safety And Efficacy ◽  
Patient Reported

Abstract BACKGROUND For patients with operable intracranial neoplasms, there are opportunities to augment local control beyond traditional methods, such as external beam radiation therapy. Brachytherapy, the implantation of radioactive sources into the resection cavity, can be useful in this setting by providing immediate initiation of radiation and limiting the exposure of surrounding normal tissue to radiation. Traditional intracranial brachytherapy has been limited by uneven dose distributions, complicated workflows, extended procedural times, cost of dedicated equipment, and frequent adverse events. To address these issues, a permanently implanted device with Cs-131 radiation seeds embedded in a bioresorbable collagen carrier tile (GammaTile, GT Medical Technologies, Tempe, AZ USA) was developed. Described as surgically targeted radiation therapy (STaRT), it is FDA-cleared for use in newly-diagnosed malignant intracranial neoplasms and recurrent intracranial tumors, and has demonstrated excellent safety and efficacy in early commercial use. The primary objectives of this multicenter, prospective, observational (phase IV) registry study are to evaluate “real-world” clinical outcomes and patient-reported outcomes that measure the safety and efficacy of STaRT using the GammaTile. METHODS Patients undergoing resection (R) of brain tumors with intra-operative GammaTile placement are eligible for enrollment. Planned sample size is 600 at up to 50 enrolling sites. First subject was enrolled 10/14/2020. Tumor pathology, overall survival, radiation- and surgery-related adverse events, patient- and provider-reported quality of life, serial MRIs, and timing of surgical bed and/or distant recurrence are collected. Powered primary endpoints for recurrent brain metastases, recurrent glioblastoma, and recurrent meningioma (surgical bed-progression free survival (PFS), overall survival, and PFS, respectively), compare STaRT to standard-of-care benchmarks. Results will be used to improve awareness and access to this treatment, benchmark clinical outcomes in the real-world setting, allow for comparisons to existing treatments, facilitate the design of future clinical trials, and contribute to the optimal sequencing of treatments for intracranial neoplasms.

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