QOLP-15. FEASIBILITY OF AN ELECTRONIC PATIENT REPORTED STEROID TOXICITY MONITORING PROGRAM IN PATIENTS WITH MALIGNANT GLIOMAS

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi186-vi186
Author(s):  
Jared Macher ◽  
Andrea Wasilewski
Keyword(s):  
Malignant Gliomas ◽  
Monitoring Program ◽  
Completion Rate ◽  
Toxicity Monitoring ◽  
Steroid Toxicity ◽  
Patient Reported ◽  
Clinically Significant ◽  
Toxicity Scores ◽  
The University ◽  
Electronic Questionnaires

Abstract OBJECTIVE To determine the feasibility of a longitudinal, electronic, patient-reported survey of steroid toxicity in patients with malignant glioma (MG). BACKGROUND Corticosteroids are frequently used for management of cerebral edema in MG, with side effects resulting from prolonged use or high dosage. Corticosteroid use is common and may negatively impact quality of life (QOL) and survival in MG. DESIGN/METHODS We prospectively enrolled patients with MG receiving neuro-oncologic care at the University of Rochester with or without their caregivers on an IRB-approved study. Subjects received 12 weekly electronic questionnaires through a secure health portal focused on symptoms of corticosteroid toxicities, dosing and functional status. Weekly toxicity scores were calculated based on the number of reported toxicities (0-17). Completed questionnaires were reviewed by a care team member to inform clinical management. Corticosteroid dosing adjustments were documented in the medical record. Feasibility was defined as an overall questionnaire completion rate of 70%. RESULTS 11 patient/caregiver pairs were enrolled (11 patients, including 9 with caregivers). Median patient age was 58. Patient tumors were glioblastoma (82%), anaplastic astrocytoma (9%) and anaplastic oligodendroglioma (9%). Phase of treatment was concurrent (55%), adjuvant (36%) and recurrence (9%). Median dexamethasone does at study start and conclusion were 4mg/day and 3mg/day. Median weekly toxicity score was 5/17 (range: 0-14). The most common toxicities were muscle weakness, sleep disturbance and weight gain and were reported by 82% of participants. Overall questionnaire completion rate was 81%. Ten percent of questionnaires resulted in clinically significant symptoms requiring follow-up from a provider. CONCLUSION Patients with MG experience frequent corticosteroid toxicities. Electronic corticosteroid toxicity monitoring is feasible in patients with MG and may lead to changes in management. Future studies are needed to assess utility of this tool and impact on QOL and survival.

Collecting patient reported outcomes to facilitate prescription opioid management: Development and testing of the Opioid Management App (OM-App) (Preprint)

2020 ◽  
Author(s):  
Jessica Robinson-Papp ◽  
Gabriela Cedillo ◽  
Richa Deshpande ◽  
Mary Catherine George ◽  
Qiuchen Yang ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Pain Intensity ◽  
Risk Behaviors ◽  
Digital Health ◽  
Monitoring Program ◽  
Prescription Opioid ◽  
Research Database ◽  
Cross Sectional ◽  
Study Duration ◽  
Patient Reported

BACKGROUND Collecting patient-reported data needed by clinicians to adhere to opioid prescribing guidelines represents a significant time burden. OBJECTIVE We developed and tested an opioid management app (OM-App) to collect these data directly from patients. METHODS OM-App used a pre-existing digital health platform to deliver daily questions to patients via text-message and organize responses into a dashboard. We pilot tested OM-App over 9 months in 40 diverse participants with HIV who were prescribed opioids for chronic pain. Feasibility outcomes included: ability to export/integrate OM-App data with other research data; patient-reported barriers and adherence to OM-App use; capture of opioid-related harms, risk behaviors and pain intensity/interference; comparison of OM-App data to urine drug testing, prescription drug monitoring program data, and validated questionnaires. RESULTS OM-App data was exported/integrated into the research database after minor modifications. Thirty-nine of 40 participants were able to use OM-App, and over the study duration 70% of all OM-App questions were answered. Although the cross-sectional prevalence of opioid-related harms and risk behaviors reported via OM-App was low, some of these were not obtained via the other measures, and over the study duration all queried harms/risks were reported at least once via OM-App. Clinically meaningful changes in pain intensity/interference were captured. CONCLUSIONS OM-App was used by our diverse patient population to produce clinically relevant opioid- and pain-related data, which was successfully exported and integrated into a research database. These findings suggest that OM-App may be a useful tool for remote monitoring of patients prescribed opioids for chronic pain. CLINICALTRIAL NCT03669939 INTERNATIONAL REGISTERED REPORT RR2-doi:10.1016/j.conctc.2019.100468

scholarly journals Trajectories of fatigue in actively treated patients with established rheumatoid arthritis starting biologic DMARD therapy

RMD Open ◽  
2020 ◽  
Vol 6 (3) ◽  
pp. e001372
Author(s):  
Sella Aarrestad Provan ◽  
Brigitte Michelsen ◽  
Joseph Sexton ◽  
Tillmann Uhlig ◽  
Hilde Berner Hammer
Keyword(s):  
Rheumatoid Arthritis ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Logistic Regression Models ◽  
Patient Reported ◽  
Biologic Dmard ◽  
Clinically Significant

ObjectivesTo define fatigue trajectories in patients with rheumatoid arthritis (RA) who initiate biological DMARD (bDMARD) treatment, and explore baseline predictors for a trajectory of continued fatigue.MethodsOne-hundred and eighty-four patients with RA initiating bDMARDs were assessed at 0, 1, 2, 3, 6 and 12 months. Swollen and tender joint counts, patient reported outcomes (PROMs), blood samples and ultrasound examinations were collected at each time point. Fatigue was assessed by the fatigue Numeric Rating Scale (0–10) from the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire. Clinically significant fatigue was predefined as fatigue ≥4. Three trajectories of interest were defined according to level of RAID fatigue: no fatigue (≤3 at 5/6 visits), improved fatigue (≥4 at start, but ≤3 at follow-up) and continued fatigue (≥4 at 5/6 visits). Baseline variables were compared between groups by bivariate analyses, and logistic regression models were used to explore baseline predictors of continued vs improved fatigue.ResultsThe majority of patients starting bDMARD therapy followed one of three fatigue trajectories, (no fatigue; n=61, improved; n=33 and continued fatigue; n=53). Patients with continued fatigue were more likely to be anti–citrullinated protein antibody and/or rheumatoid factor positive and had higher baseline PROMs compared to the other groups, while there were no differences between the groups for variables of inflammation including. Patient global, tender joint count and anxiety were predictors for the continued fatigue trajectory.DiscussionA trajectory of continued fatigue was determined by PROMs and not by inflammatory RA disease activity.

scholarly journals QOLP-04. PILOT STUDY OF A VIDEOCONFERENCE-BASED PSYCHOLOGICAL INTERVENTION FOR FAMILY CAREGIVERS OF PATIENTS WITH MALIGNANT GLIOMAS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii175-ii175
Author(s):  
Deborah Forst ◽  
Michelle Mesa ◽  
Emilia Kaslow-Zieve ◽  
Areej El-Jawahri ◽  
Joseph Greer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Self Efficacy ◽  
Coping Skills ◽  
Malignant Gliomas ◽  
Anxiety Symptoms ◽  
Structured Interviews ◽  
Post Intervention ◽  
Clinically Significant ◽  
And Coping

Abstract BACKGROUND Caregivers of patients with malignant gliomas experience substantial anxiety symptoms while caring for someone with progressive neurological decline. Yet, interventions to reduce psychological distress and improve quality of life (QoL) in this caregiver population are lacking. METHODS We conducted an open pilot study evaluating feasibility and acceptability of a cognitive behavioral therapy-based intervention for caregivers of patients with malignant gliomas with clinically significant anxiety (Generalized Anxiety Disorder [GAD-7] score ≥ 5). Caregivers participated in six videoconference sessions with a mental health provider. We defined the intervention as feasible if ≥ 70% of eligible caregivers enrolled and ≥ 70% of those enrolled completed ≥ 50% of sessions. We evaluated intervention acceptability in semi-structured interviews. Caregivers completed baseline and post-intervention surveys assessing anxiety and depression symptoms (Hospital Anxiety and Depression Scale), QoL (Caregiver Oncology Quality of Life Questionnaire), caregiving burden (Caregiver Reaction Assessment), self-efficacy (Lewis Cancer Self-Efficacy Scale), and perceived coping skills (Measure of Current Status-Part A). We explored post-intervention changes using paired t-tests. RESULTS We obtained consent from 70.0% (21/30) of caregivers approached, of which 66.7% (14/21) had clinically significant anxiety and thus were eligible to participate (mean age=55.7 years, 64.3% female). Among enrolled caregivers, 71.4% (10/14) completed ≥ 50% of sessions. In semi-structured interviews, all participants found the intervention helpful and valued the ability to participate remotely via videoconference. Among caregivers who completed at least one session, 80.0% (8/10) completed all assessments and were included in analyses. Post-intervention, caregivers reported reduced anxiety symptoms (P=.02) and improved QoL (P=.03) and coping skills (P=.001). We found no significant change in depression, caregiving burden, or self-efficacy. CONCLUSION Our videoconference-based intervention is feasible and acceptable to caregivers. Participants reported significant improvements in anxiety symptoms, quality of life, and coping skills post-intervention, supporting further investigation of the intervention in a randomized controlled trial.

Timeline for Maximal Subjective Outcome Improvement After Anterior Cruciate Ligament Reconstruction

2018 ◽  
Vol 47 (10) ◽  
pp. 2501-2509 ◽  
Author(s):  
Avinesh Agarwalla ◽  
Richard N. Puzzitiello ◽  
Joseph N. Liu ◽  
Gregory L. Cvetanovich ◽  
Anirudh K. Gowd ◽  
...  
Keyword(s):  
Systematic Review ◽  
Anterior Cruciate Ligament ◽  
Acl Reconstruction ◽  
Clinical Significance ◽  
Cruciate Ligament ◽  
Return To Sport ◽  
Pubmed Database ◽  
Patient Reported ◽  
Clinically Significant ◽  
Anterior Cruciate

Background: Anterior cruciate ligament (ACL) tears are one of the most common traumatic knee injuries experienced by athletes. Return to sport is considered the pinnacle endpoint among patients receiving ACL reconstruction. However, at the time of return to sport, patients may not be participating at their previous levels of function, as defined by clinical metrics. Purpose: To establish when patients perceive maximal subjective medical improvement according to patient-reported outcome measures (PROMs). Study Design: Systematic review. Methods: A systematic review of the PubMed database was conducted to identify studies that reported sequential PROMs up to a minimum of 2 years after ACL reconstruction. Pooled analysis was conducted for PROMs at follow-up points of 3 months, 6 months, 1 year, and 2 years. Clinically significant improvement was determined between pairs of intervals with the minimal clinically important difference. Results: This review contains 30 studies including 2253 patients who underwent ACL reconstruction. Clinically significant improvement in the KOOS (Knee injury and Osteoarthritis Outcome Score) was seen up to 1 year after ACL reconstruction, but no clinical significance was noted from 1 to 2 years. Clinically significant improvement in the IKDC (International Knee Documentation Committee) and Lysholm questionnaires was seen up to 6 months postoperatively, but no clinical significance was noted beyond that. Conclusion: After ACL reconstruction, maximal subjective medical improvement is established 1 year postoperatively, with no further perceived clinical improvement beyond this time point according to current PROMs. The KOOS may be a more responsive metric to subjective improvements in this patient cohort than other patient-reported outcomes, such as the IKDC and Lysholm. Clinical Relevance: After ACL reconstruction, patients perceive interval subjective improvements until 1 year postoperatively.

scholarly journals Clinically Significant Outcome Improvement After Hip Arthroscopy in Patients With Femoroacetabular Impingement Syndrome and Severe Femoral Torsion

2021 ◽  
Vol 9 (10) ◽  
pp. 232596712110345
Author(s):  
Steven F. DeFroda ◽  
Thomas D. Alter ◽  
Blake M. Bodendorfer ◽  
Alexander C. Newhouse ◽  
Felipe S. Bessa ◽  
...  
Keyword(s):  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Impingement Syndrome ◽  
Harris Hip Score ◽  
Femoral Torsion ◽  
Outcome Score ◽  
Femoroacetabular Impingement Syndrome ◽  
Patient Reported ◽  
Outcome Improvement ◽  
Clinically Significant

Background: The influence of femoral torsion on clinically significant outcome improvement after hip arthroscopy for femoroacetabular impingement syndrome (FAIS) has not been well-studied. Purpose: To quantify femoral torsion in FAIS patients using magnetic resonance imaging (MRI) and explore the relationship between femoral torsion and clinically significant outcome improvement after hip arthroscopy. Study Design: Cohort study; Level of evidence, 3. Methods: Included were patients who underwent hip arthroscopy for FAIS between January 2012 and August 2018 and had 2-year follow-up and preoperative MRI scans containing transcondylar slices of the knee. Participants were categorized as having severe retrotorsion (SR; <0°), normal torsion (NT; 0°-25°), and severe antetorsion (SA; >25°) as measured on MRI. Patient-reported outcomes (PROs) included the Hip Outcome Score–Activities of Daily Living, Hip Outcome Score–Sports Subscale, modified Harris Hip Score, 12-item International Hip Outcome Tool (iHOT-12), and visual analog scale (VAS) for pain and satisfaction. Achievement of Patient Acceptable Symptom State (PASS) and substantial clinical benefit (SCB) were analyzed among cohorts. Results: Included were 183 patients (SR, n = 13; NT, n = 154; SA, n = 16) with a mean age, body mass index, and femoral torsion of 30.6 ± 12.1 years, 24.0 ± 4.4 kg/m2, and 12.55° ± 9.58°, respectively. The mean torsion was –4.5° ± 2.6° for the SR, 12.1° ± 6.8° for the NT, and 31.0° ± 3.6° for the SA group. There were between-group differences in the proportion of patients who achieved PASS and SCB on the iHOT-12, pain VAS, and any PRO ( P < .05). Post hoc analysis indicated that the SA group achieved lower rates of PASS and SCB on the iHOT-12 and pain VAS, and lower rates of PASS on any PRO versus the SR group ( P < .05); the SR group achieved higher rates of PASS and SCB on pain VAS scores versus the NT group ( P = .003). Conclusion: The orientation and severity of femoral torsion during hip arthroscopy influenced the propensity for clinically significant outcome improvement. Specifically, patients with femoral retrotorsion and femoral antetorsion had higher and lower rates of clinically significant outcome improvement, respectively.

scholarly journals Factors affecting the completion rate of scientific students research - Consider at University of Economics and Law

2016 ◽  
Vol 19 (3) ◽  
pp. 109-121
Author(s):  
Tuan Anh Nguyen
Keyword(s):  
Student Motivation ◽  
Scientific Research ◽  
Theoretical Framework ◽  
Completion Rate ◽  
Factors Affecting ◽  
Independent Variables ◽  
The University ◽  
International Academy

This paper aims to analyze the factors affecting the completion rate of scientific research by UEL students under the theoretical framework of International Academy of Science. Based on the survey of students who carried out the scientific research at University of Economics and Law from 2008 to 2013, we found that the model explains 41.7% the completion rate with independent variables of student motivation, support from the university and the instructor capacity.

Patient-Reported Efficacy of the University of California, San Francisco, Custom Pectus Carinatum Orthosis

2021 ◽  
Vol 33 (2) ◽  
pp. 96-100
Author(s):  
Samantha Stauffer ◽  
Corin Shirley ◽  
Benjamin Fortson ◽  
Nicole Henry ◽  
Chrysta Irolla ◽  
...  
Keyword(s):  
San Francisco ◽  
University Of California ◽  
Pectus Carinatum ◽  
Patient Reported ◽  
The University

Implementing Digital Technology to Transitioning a Clinical Trial to a Registry – TAILOR-PCI Digital Study: Methods/Study Design (Preprint)

2021 ◽  
Author(s):  
Robert Avram ◽  
Derek So ◽  
Erin Iturriaga ◽  
Julia Byrne ◽  
Ryan Lennon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
The United States ◽  
Completion Rate ◽  
Phone Call ◽  
Consent Rate ◽  
Digital Platform ◽  
Phone Calls ◽  
Patient Reported ◽  
Research Platform

BACKGROUND TAILOR-PCI was the largest cardiovascular genotype-based randomized clinical trial (RCT) investigating whether CYP2C19 genotype-guided selection of oral P2Y12 inhibitor therapy improved ischemic outcomes after percutaneous coronary intervention (PCI). The TAILOR-PCI Digital Registry was a novel proof-of-concept study that evaluated the feasibility of extending the main RCT follow-up period using a remote digital platform. OBJECTIVE To describe patients onboarding, engagement and results of a digital registry after enrollment in a RCT. METHODS In this intervention study, previously enrolled TAILOR-PCI patients in the United States and Canada within 24 months of randomization were invited by letters containing a URL to the TAILOR-PCI Digital Registry website (http://tailorpci.eurekaplatform.org), instructing them to download the study app. Patients previously enrolled in the TAILOR-PCI study, with a smartphone, were eligible to join the Digital Registry. Those who did not respond to the letter were contacted by phone to survey reasons for non-participation and were invited again to join the study. A direct-to-patient digital research platform (the Eureka Research Platform) was used to onboard, consent and enrol patients in the Digital Registry. Patients were asked to complete health-related surveys and provide follow-up data digitally. Consent rate to the Digital Registry, duration of participation in the Digital Registry and monthly activity completion rate. The hypothesis being tested was formulated before data collection began. RESULTS After the parent trial was completed, letters were mailed to 907 eligible patients (representing 19% of total enrolled in the RCT) across 24 sites, who were within 15.6 ± 5.2 months after randomization leading to 290 unique individuals visits to the Digital Registry website. Among those invited, 110 patients (12%) consented: 45 (41%) after the letter, 37 (34%) after the 1st phone call and 28 (25%) after a 2nd call. Of the 862 who didn’t consent after the letter, 453 patients (53%) did not respond to repeated phone calls and among the 409 patients who responded, 171 (41%) declined participation stating lack of time, 128 (31%), due to lack of smartphone and 47 (11%) due to difficulty understanding what was expected of them in the study. Patients who consented were older, had less diabetes or tobacco use; a greater proportion had bachelor's degrees or higher and were more computer literate than those who did not consent. The average completion rate of the 920 available monthly electronic visits was 64.9±7.6% without a decrease in this rate throughout the study duration. There were no differences between randomization arms in any patient reported outcomes using the digital platform. CONCLUSIONS Extended follow-up after enrollment in a RCT using a digital registry is technically feasible but was limited due to inability to contact most eligible patients, lack of time or access to a smartphone. Among those enrolled, most patients completed required electronic visits. Enhanced recruitment methods, such as introduction of the digital study at the time of RCT consent, provision of smartphone and robust study support for onboarding, should be explored further. CLINICALTRIAL TAILOR-PCI (Clinicaltrials.gov: NCT01742117)

Retina Injury After Dexamethasone Injection Into a Vitrectomized Eye

2020 ◽  
Vol 4 (6) ◽  
pp. 538-540
Author(s):  
Michael S. Elliott ◽  
Sandra R. Montezuma
Keyword(s):  
Macular Edema ◽  
Vitreous Hemorrhage ◽  
Signs And Symptoms ◽  
Internal Limiting Membrane ◽  
Dexamethasone Implant ◽  
Intravitreal Dexamethasone Implant ◽  
Patient Reported ◽  
Clinically Significant ◽  
The Right ◽  
Intravitreal Dexamethasone

Purpose: This work reports a case of retinal and vitreous hemorrhage after a dexamethasone (Ozurdex, Allergan) intravitreal implant injection to treat clinically significant macular edema (ME) in a patient with moderate nonproliferative diabetic retinopathy. Methods: A 61-year-old woman who had a vitrectomy 3 years prior in the right eye underwent intravitreal dexamethasone implant injection in the right eye. Immediately after the injection, the patient noted numerous floaters, with visual acuity decline from 20/30 before injection, to counting fingers at 3 feet after injection. Dilated examination revealed the dexamethasone implant resting against the retina, just inferior to the inferior arcade. On 360° fundus examination, the retina was found to be flat and attached. Optical coherence tomography of the macula demonstrated that the dexamethasone implant was preretinal, possibly having lifted the internal limiting membrane. Results: Thirty minutes after the injection, the patient reported that her vision was starting to clear. The patient was informed about what had transpired and warned about signs and symptoms of retinal detachment. She canceled her 1-week follow-up appointment because her vision returned to baseline. By 4 weeks post injection, her vision was 20/20 without macular edema. Conclusions: This case represents the first reported instance in which retinal impact by an Ozurdex implant was observed without treatment and vision recovered to baseline.

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