scholarly journals Association between Patient-Reported Outcomes and Survival in Patients with Advanced Urothelial Carcinoma Treated with Atezolizumab

2021 ◽  
pp. 1-8
Author(s):  
Eugene Tan ◽  
Ahmad Y. Abuhelwa ◽  
Sarah Badaoui ◽  
Natansh D. Modi ◽  
Michael D. Wiese ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Global Health ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Discrimination Performance ◽  
Appetite Loss ◽  
Patient Reported ◽  
Pre Treatment ◽  
Advanced Urothelial Carcinoma ◽  
Ecog Ps

BACKGROUND: Atezolizumab is an immune checkpoint inhibitor (ICI) and a frontline treatment of patients with cisplatin-ineligible advanced urothelial carcinoma (UC). There is limited evidence on the prognostic value of patient reported outcomes (PROs) in advanced UC treatment, particularly in the context of ICI therapy. OBJECTIVE: To investigate the prognostic association of PROs with survival in patients with advanced UC treated with atezolizumab. METHODS: This study used data from 467 patients with advanced UC initiating atezolizumab in the IMvigor211 trial. Pre-treatment PROs association with overall survival (OS) and progression free survival (PFS) was assessed using Cox proportional hazard analysis. PROs were recorded via the European Organisation for Research and Treatment of Cancer QLQ-C30. Discrimination performance was assessed via the C-statistic (c). RESULTS: Patient reported physical function, pain, appetite loss, global health, fatigue, role function, constipation, nausea and vomiting, dyspnoea, and insomnia were significantly associated with OS and PFS on univariable and adjusted analysis (P <  0.05). Physical function (c = 0.63), pain (c = 0.63), appetite loss (c = 0.62), global health status (c = 0.62), and fatigue (c = 0.62), were the most prognostic factors of OS. The OS discrimination performance of physical function (c = 0.61) was superior to ECOG PS (c = 0.58). Of patients assessed by investigators as having no performance restrictions (ECOG PS of 0), 38 (18%) and 91 (42%) self-reported low and intermediate physical function scores, respectively. CONCLUSION: Pre-treatment PROs were identified as independent prognostic factors of OS and PFS. Patient-reported physical function was more prognostic of OS than ECOG PS. This highlights a potential for PROs to enable improved patient stratification in ICI trials.

Impact of Preoperative Opioid Use on 2-Year Patient-Reported Outcomes in Knee Surgery Patients

2020 ◽  
Author(s):  
Ali Aneizi ◽  
Patrick M. J. Sajak ◽  
Aymen Alqazzaz ◽  
Tristan Weir ◽  
Cameran I. Burt ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Knee Surgery ◽  
The Body ◽  
Pain Interference ◽  
Opioid Use ◽  
Opioid Prescription ◽  
Social Satisfaction ◽  
Patient Reported ◽  
Met Expectations

AbstractThe objectives of this study are to assess perioperative opioid use in patients undergoing knee surgery and to examine the relationship between preoperative opioid use and 2-year postoperative patient-reported outcomes (PROs). We hypothesized that preoperative opioid use and, more specifically, higher quantities of preoperative opioid use would be associated with worse PROs in knee surgery patients. We studied 192 patients undergoing knee surgery at a single urban institution. Patients completed multiple PRO measures preoperatively and 2-year postoperatively, including six patient-reported outcomes measurement information system (PROMIS) domains; the International Knee Documentation Committee (IKDC) questionnaire, numeric pain scale (NPS) scores for the operative knee and the rest of the body, Marx's knee activity rating scale, Tegner's activity scale, International Physical Activity Questionnaire, as well as measures of met expectations, overall improvement, and overall satisfaction. Total morphine equivalents (TMEs) were calculated from a regional prescription monitoring program. Eighty patients (41.7%) filled an opioid prescription preoperatively, and refill TMEs were significantly higher in this subpopulation. Opioid use was associated with unemployment, government insurance, smoking, depression, history of prior surgery, higher body mass index, greater comorbidities, and lower treatment expectations. Preoperative opioid use was associated with significantly worse 2-year scores on most PROs, including PROMIS physical function, pain interference, fatigue, social satisfaction, IKDC, NPS for the knee and rest of the body, and Marx's and Tegner's scales. There was a significant dose-dependent association between greater preoperative TMEs and worse scores for PROMIS physical function, pain interference, fatigue, social satisfaction, NPS body, and Marx's and Tegner's scales. Multivariable analysis confirmed that any preoperative opioid use, but not quantity of TMEs, was an independent predictor of worse 2-year scores for function, activity, and knee pain. Preoperative opioid use and TMEs were neither independent predictors of met expectations, satisfaction, patient-perceived improvement, nor improvement on any PROs. Our findings demonstrate that preoperative opioid use is associated with clinically relevant worse patient-reported knee function and pain after knee surgery.

scholarly journals Which patient-reported outcomes do rheumatology patients find important to track digitally? A real-world longitudinal study in ArthritisPower

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
W. Benjamin Nowell ◽  
Kelly Gavigan ◽  
Carol L. Kannowski ◽  
Zhihong Cai ◽  
Theresa Hunter ◽  
...  
Keyword(s):  
Physical Function ◽  
Lupus Erythematosus ◽  
Patient Reported Outcomes ◽  
Treatment Effectiveness ◽  
Time Window ◽  
Joint Stiffness ◽  
Summary Score ◽  
Longitudinal Tracking ◽  
Patient Reported

Abstract Background Patient-reported outcomes (PROs) are increasingly used to track symptoms and to assess disease activity, quality of life, and treatment effectiveness. It is therefore important to understand which PROs patients with rheumatic and musculoskeletal disease consider most important to track for disease management. Methods Adult US patients within the ArthritisPower registry with ankylosing spondylitis, fibromyalgia syndrome, osteoarthritis, osteoporosis, psoriatic arthritis, rheumatoid arthritis, and systemic lupus erythematosus were invited to select between 3 and 10 PRO symptom measures they felt were important to digitally track for their condition via the ArthritisPower app. Over the next 3 months, participants (pts) were given the option to continue tracking their previously selected measures or to remove/add measures at 3 subsequent monthly time points (month [m] 1, m2, m3). At m3, pts prioritized up to 5 measures. Measures were rank-ordered, summed, and weighted based on pts rating to produce a summary score for each PRO measure. Results Among pts who completed initial selection of PRO assessments at baseline (N = 253), 140 pts confirmed or changed PRO selections across m1–3 within the specified monthly time window (28 days ± 7). PROs ranked as most important for tracking were PROMIS Fatigue, Physical Function, Pain Intensity, Pain Interference, Duration of Morning Joint Stiffness, and Sleep Disturbance. Patient’s preferences regarding the importance of these PROs were stable over time. Conclusion The symptoms that rheumatology patients prioritized for longitudinal tracking using a smartphone app were fatigue, physical function, pain, and morning joint stiffness.

scholarly journals FRI0048 NUMBER NEEDED TO TREAT TO ACHIEVE MINIMUM CLINICALLY SIGNIFICANT DIFFERENCES IN PATIENT-REPORTED OUTCOMES IN PATIENTS TREATED WITH BARICITINIB

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 599.1-600
Author(s):  
V. Strand ◽  
L. Sun ◽  
J. Ross Terres ◽  
C. L. Kannowski
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Bodily Pain ◽  
Health Assessment ◽  
Number Needed To Treat ◽  
Chronic Illness Therapy ◽  
Sf 36 ◽  
Patient Reported ◽  
Assessment Questionnaire ◽  
Questionnaire Disability

Background:Baricitinib (BARI) provided rapid and sustained improvements in patient-reported outcomes (PROs) in randomized, controlled trials (RCTs) in patients (pts) with active rheumatoid arthritis (RA) and inadequate responses (IR) to methotrexate (MTX) (RA-BEAM;NCT01710358)1,2and biologic DMARDs (bDMARD-IR; RA-BEACON;NCT01721044)3,4.Objectives:To determine the number needed to treat (NNT) to report improvements ≥minimum clinically important differences (MCIDs) in multiple PROs at Week (Wk) 12 after treatment with BARI 4-mg in RA-BEAM and BARI 2-mg or BARI 4-mg in RA-BEACON. NNTs ≤10 vs placebo (PBO) are considered clinically meaningful.Methods:Evaluated PROs with respective MCID definitions included Patient Global Assessment of Disease Activity (PtGA, 0-100 mm visual analog scale [VAS], MCID ≥10 mm), pain (0-100 mm VAS, MCID ≥10 mm), physical function (Health Assessment Questionnaire-Disability Index, MCID ≥0.22 points), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], MCID≥4.0), and health-related quality of life (SF-36 physical component summary [PCS: MCID ≥2.5] and domain scores: physical function [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], mental health [MH], MCID ≥5.0).5The percentages of pts reporting improvements ≥MCID were determined at Wk 12. NNTs were calculated as 1/difference in response rates between BARI 2-mg or 4-mg and PBO.Results:At Wk 12, percentages of pts reporting clinically meaningful improvements were greater and statistically different from PBO (p<0.01) with BARI 2-mg and 4-mg across most PROs in both RCTs. Most NNTs were ≤10. (Figure)Conclusion:Across different populations, MTX-IR and bDMARD-IR pts with active RA reported clinically meaningful improvements in PROs after BARI treatment. The NNTs in these analyses indicate that <10 pts need to be treated with BARI 2- or 4-mg to report a clinically meaningful benefit.References:[1]Taylor et al. NEJM, 2017;376: 652-62[2]Keystone et al. Ann Rheum Dis, 2017;76:1853-61[3]Genovese et al. NEJM, 2016; 374: 1243-52[4]Smolen et al. Ann Rheum Dis, 2017; 76: 694-700[5]Strand et al. J Rheumatol, 2011; 38: 1720-27Figure.Percentages of patients reporting improvements ≥MCID with baricitinib vs placebo and associated NNTs for baricitinib in RA-BEAM and RA-BEACON. *p<0.05; **p<0.01; ***p<0.001. Abbreviations: BP, bodily pain; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; GH, general health; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCID, minimum clinically important difference; MH, mental health; NA, not applicable (ie, difference between treatment and placebo is not statistically significant, confidence interval of NNT is not calculated); NNT, numbers needed to treat; Pain, Patient’s assessment of pain; PCS, physical component score; PF, physical function; PtGA, Patient’s Global Assessment of Disease Activity; RE, role emotional; RP, role physical; SF-36, Short Form-36; SF, social functioning; VT, vitalityDisclosure of Interests:Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Luna Sun Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jorge Ross Terres Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company

Patient-reported outcomes across cerebrovascular event types

Neurology ◽  
2018 ◽  
Vol 91 (23) ◽  
pp. e2182-e2191 ◽  
Author(s):  
Irene L. Katzan ◽  
Andrew Schuster ◽  
Christopher Newey ◽  
Ken Uchino ◽  
Brittany Lapin
Keyword(s):  
Ischemic Stroke ◽  
Executive Function ◽  
Physical Function ◽  
Patient Reported Outcomes ◽  
Social Roles ◽  
Factors Associated ◽  
Cerebrovascular Events ◽  
Patient Reported ◽  
Health Domains ◽  
Domain Scores

ObjectivesTo compare the degrees to which 8 domains of health are affected across types of cerebrovascular events and to identify factors associated with domain scores in different event types.MethodsThis was an observational cohort study of 2,181 patients with ischemic stroke, intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), or TIA in a cerebrovascular clinic from February 17, 2015, to June 2, 2017 who completed Quality of Life in Neurologic Disorders executive function and the following Patient-Reported Outcomes Measurement Information System scales as part of routine care: physical function, satisfaction with social roles, fatigue, anxiety, depression, pain interference, and sleep disturbance.ResultsAll health domains were affected to similar degrees in patients with ICH, SAH, and ischemic stroke after adjustment for disability and other clinical factors, whereas patients with TIA had worse adjusted scores for 5 of the 8 domains of health. Female sex, younger age, lower income, and event <90 days were associated with worse scores in multiple domains. Factors associated with health domain scores were similar for all cerebrovascular events. Most affected domains for all were physical function, satisfaction with social roles, and executive function.ConclusionsThe subtype of stroke (ischemic stroke, ICH, and SAH) had similar effects in multiple health domains, while patients with TIA had worse adjusted outcomes, suggesting that the mechanisms for outcomes after TIA may differ from those of other cerebrovascular events. The most affected domains across all event types were physical function, satisfaction with social roles, and executive function, highlighting the need to develop effective interventions to improve these health domains in survivors of these cerebrovascular events.

scholarly journals Within-subjects Effects of Standardized Prosthetic Socket Modifications on Physical Function and Patient-Reported Outcomes

2021 ◽  
Author(s):  
William Anderst ◽  
Goeran Fiedler ◽  
Kentaro Onishi ◽  
Gina McKernan ◽  
Tom Gale ◽  
...  
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Design Method ◽  
Pressure Sensors ◽  
Residual Limb ◽  
Prosthetic Socket ◽  
Large Patient ◽  
Increased Risk ◽  
Patient Reported ◽  
And Function

Abstract • Background: Among the challenges of living with lower limb loss is the increased risk of long-term health problems that can be either attributed directly to the amputation surgery and/or prosthetic rehabilitation or indirectly to a disability-induced sedentary lifestyle. These problems are exacerbated by poorly fit prosthetic sockets. There is a knowledge gap regarding how the socket design affects in-socket mechanics, and how in-socket mechanics affect patient-reported comfort and function. The objectives of this study are: 1) to gain a better understanding of how in-socket mechanics of the residual limb in transfemoral amputees are related to patient-reported comfort and function, 2) to identify clinical tests that can streamline the socket design process, and 3) to evaluate the efficacy and cost of a novel, quantitatively informed socket optimization process.• Methods: Users of transfemoral prostheses will be asked to walk on a treadmill wearing their current socket plus 8 different check sockets with designed changes in different structural measurements that are likely to induce changes in residual limb motion, skin strain, and pressure distribution within the socket. Dynamic biplane radiography and pressure sensors will be used to measure in-socket residual limb mechanics. Patient-reported outcomes will also be collected after wearing each socket. The effects of in-socket mechanics on both physical function and patient-reported outcomes (aim 1) will be assessed using a generalized linear model. Partial correlation analysis will be used to examine the association between research grade measurements and readily available clinical measurements (aim 2). In order to compare the new quantitative design method to the Standard of Care, patient reported outcomes and cost will be compared between the two methods, utilizing the Wilcoxon Mann-Whitney non-parametric test (aim 3).• Discussion: Knowledge on how prosthetic socket modifications affect residual bone and skin biomechanics itself can be applied to devise future socket designs, and the methodology can be used to investigate and improve such designs, past and present. Apart from saving time and costs, this may result in better prosthetic socket fit for a large patient population, thus increasing their mobility, participation, and overall health-related quality of life. • Trial registration: clinicaltrials.gov: NCT05041998

scholarly journals Patient-Reported Outcomes after Exosym Bracing (Intrepid Dynamic Exoskeletal Orthosis (IDEO)) in the Civilian Population

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0019
Author(s):  
Ryan Hadden ◽  
James Meeker ◽  
Jason Weiss ◽  
Austin Thompson
Keyword(s):  
Physical Function ◽  
Patient Reported Outcomes ◽  
Pain Modulation ◽  
Pain Interference ◽  
Average Score ◽  
Foot And Ankle ◽  
Kinetic Chain ◽  
Civilian Population ◽  
Patients Âgés ◽  
Patient Reported

Category: Ankle Arthritis, Orthosis Introduction/Purpose: When it comes to ambulation, the dynamic interplay of anatomy at the foot and ankle affords weight acceptance, stability and force production. The outcome is gait efficiency. Various musculoskeletal injuries challenge gait biomechanics. While surgical management may address the fault in kinetic chain, it may not fully address the problem of pain, functional outcome and patient satisfaction. Non-surgical interventions such as bracing using ankle foot orthoses (AFO) aim to assist, restore and redirect weightbearing forces with immobility in mind. As an energy-storing AFO, however, the IDEO was created to improve functional performance in veterans after limb salvage procedures. The goal of the study was to evaluate outcomes following use of Exosym (or IDEO) bracing for foot and ankle pathologies in the civilian population. Methods: Through review of one institution’s electronic medical record, 29 patients ages 18 years or older who were prescribed the Exosym brace by a single foot and ankle surgeon over a 5-year period were identified. A composite questionnaire including patient-reported outcomes of PROMIS SF Physical Function, PROMIS SF Pain Interference, Brace Use, and EQ-5D was obtained over the phone or by email. Results: A total of 29 patients were prescribed the brace over a 5-year period with only 18 patients receiving the brace. Insurance denying coverage was the most common reason (n=7) for patients not receiving the brace. Of the 18 patients that received the brace, 17 of them were willing to answer the questionnaire. The average age of patients with the Exosym brace was 42.3 (sd=13.8) years old with 6 (35%) being female. Patients with the Exosym brace reported an average score of 47.2 (sd=6.0) for the PROMIS Physical Function and 53.6 (sd=8.4) for the PROMIS Pain Interference. The average satisfaction with the Exosym brace was 65.5 (sd=17.6) out of a possible 100. Conclusion: Exosym bracing in various foot and ankle pathologies provides functionality and pain modulation in the civilian population that rivals respective subpopulation norms. One of the acknowledged limitations of the study is that not obtaining pre- bracing patient reported outcomes precluded evaluation of a minimum clinically important difference. However, the study was not designed to provide such data. It did, however, provide impetus to pursue a follow-up study evaluating plantar pressure changes with and without brace use, which is currently ongoing. Such knowledge may help identify which injuries would be best suited for Exosym bracing.

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