Changes In Patient-reported Outcomes Research Articles

Fatigue and Other Patient-Reported Outcomes in Patients With RRMS who Switched to Ocrelizumab: 4-Year Data From CASTING-LIBERTO (P6-3.010)

Fatigue and Other Patient-Reported Outcomes in Patients With RRMS who Switched to Ocrelizumab: 4-Year Data From CASTING-LIBERTO (P6-3.010)

The MS-LINK Outcomes Study Cohort: Study design and a descriptive analysis of baseline key PROs, disease, and sociodemographic characteristics (P13-3.010)

The MS-LINK Outcomes Study Cohort: Study design and a descriptive analysis of baseline key PROs, disease, and sociodemographic characteristics (P13-3.010)

PD43-11 IMPACT OF CYTOREDUCTIVE NEPHRECTOMY ON PATIENT REPORTED OUTCOMES

You have accessJournal of UrologyCME1 Apr 2023PD43-11 IMPACT OF CYTOREDUCTIVE NEPHRECTOMY ON PATIENT REPORTED OUTCOMES Daniel Shapiro, Viraj Master, Juliana Craig, Dattatraya Patil, Tudor Borza, Glenn Allen, Kyle Richards, David Jarrard, and E. Jason Abel Daniel ShapiroDaniel Shapiro More articles by this author , Viraj MasterViraj Master More articles by this author , Juliana CraigJuliana Craig More articles by this author , Dattatraya PatilDattatraya Patil More articles by this author , Tudor BorzaTudor Borza More articles by this author , Glenn AllenGlenn Allen More articles by this author , Kyle RichardsKyle Richards More articles by this author , David JarrardDavid Jarrard More articles by this author , and E. Jason AbelE. Jason Abel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003353.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: One goal of cytoreductive nephrectomy (CN) is to improve patients’ quality of life, but few studies have used validated patient reported outcomes (PROs) metrics to quantify the benefit of CN. The NCCN FKSI-19 is a validated 19-item questionnaire that measures tumor-specific PROs in patients with kidney cancer. This study evaluated changes in PROs in mRCC patients before and after treatment with CN using the FKSI-19 instrument. METHODS: Patients undergoing upfront CN were recruited at two institutions over two years to complete FKSI-19 forms within 30 days preoperatively and 4-6 weeks postoperatively. The FKSI-19 score ranges from 0-76 with higher scores indicating fewer symptoms. The FKSI-19 contains subdomains including disease related symptoms (DRS), DRS-emotional (DRS-E), DRS-physical (DRS-P) and functional wellbeing (FWB). Wilcoxon matched-pairs signed rank test and Fisher’s exact test were used to compare pre- and postoperative scores. Clinically meaningful improvements in FKSI-19 score were considered if the score increased ≥5 points postoperatively based on prior studies. Logistic regression was used to determine variables associated with meaningful improvements in FKSI scores. RESULTS: A total of 25 patients completed a pre and postop FKSI. Median preop FKSI was 57 (IQR 47-63) and postop 59 (IQR 51-64) (p=0.2) with a median change of+3 points. Tumor size, gender, surgical approach (open vs. laparoscopic), age, and race were not associated with change in FKSI postoperatively (p>0.05 for all). Among the domains, the DRS-E score, which ranges from 0-4, significantly improved postop (median 2 vs 3, p<0.001), indicating patients were less worried their cancer would worsen after CN. 11/25 (44%) patients had meaningful improvements in postop FKSI. Preop FKSI score was inversely associated with meaningful improvements in postop FKSI (OR 0.89 95%CI 0.8-0.96, p=0.02). The patient with the largest improvement in FKSI score was the most symptomatic preoperatively (Figure 1). CONCLUSIONS: Patients had significantly less worry about cancer progression after CN. Patients that had the most improvement in PROs tended to be more symptomatic prior to CN. This study is limited by variability in timing of the postop FKSI. Continued prospective evaluation of CN PROs will help define which patients are most likely to benefit from CN. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1122 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Shapiro More articles by this author Viraj Master More articles by this author Juliana Craig More articles by this author Dattatraya Patil More articles by this author Tudor Borza More articles by this author Glenn Allen More articles by this author Kyle Richards More articles by this author David Jarrard More articles by this author E. Jason Abel More articles by this author Expand All Advertisement PDF downloadLoading ...

Psycho-Educational and Rehabilitative Intervention to Manage Cancer Cachexia (PRICC) for Advanced Patients and Their Caregivers: Lessons Learned from a Single-Arm Feasibility Trial.

Key elements in cancer cachexia (CC) management are personalized and multimodal interventions, but it is hard for some patients to follow programs based on several components. We examined the feasibility of a bimodal intervention, including a psycho-educational component and exercises, to support patients and their caregivers in managing CC; Methods: Prospective mixed-methods pilot study explored feasibility data, changes in patient-reported outcomes, and performance outcomes over time in a convenient sample of 30 consecutive CC patients and their caregivers. Twenty-four dyads consented to participate. Twenty dyads received at least two psycho-educational sessions, so the psycho-educational component was feasible for 83.3% of the sample. Six dyads participated in at least fourteen out of twenty-seven rehabilitation sessions, so the exercise program was feasible for 25.0% of the sample. Six dyads showed compliance greater than 50% for both components of the bimodal intervention. While we did not meet our primary feasibility endpoint and had mixed acceptability, our experience provides insight into the challenges and lessons learned in implementing a primary palliative care intervention for CC. More robust studies are needed to help clinicians understand the best exercise program for CC patients, to be included in a multimodal intervention.

Prevalence of Uncontrolled Asthma despite Treatment with Medium- or High-Dose ICS/LABA Using Patient-Reported Outcomes in Japan: The KOCU (KnOwing the Controlled statUs of Asthma in Japan) Study

Introduction: Evidence on the prevalence of uncontrolled asthma upon the standard of care in Japan is scarce and inconsistent. We report the prevalence of uncontrolled asthma using the Japanese Guidelines for Asthma (JGL) 2018 and Global Initiative for Asthma (GINA) 2019 classifications in patients who are currently receiving standard-of-care treatment in a real-life setting. Methods: In this prospective, 12-week, noninterventional study, patients with asthma aged 20–75 years and continuously treated with medium- or high-dose inhaled corticosteroid (ICS)/LABA, with or without other controller(s), were assessed for their asthma control status. The demographics, clinical characteristics, treatment patterns, health care resource utilization, patient-reported outcomes (PROs), and adherence to prescribed treatments were assessed for patients classified as either controlled or uncontrolled. Results: Of 454 patients, 53.7% and 36.3% of the patients reported their asthma as uncontrolled based on the JGL and GINA criteria, respectively. Uncontrolled asthma was even higher (JGL, 75.0%; GINA, 63.5%) within the subpopulation of 52 patients receiving long-acting muscarinic antagonists (LAMAs; i.e., ICS/LABA/LAMA subpopulation). Sensitivity analysis by propensity matching identified significant odds ratios of controlled versus uncontrolled asthma for several demographics and clinical characteristics: male; sensitization to animals, fungi, or birch; comorbidities including food allergy or diabetes; and history of exacerbation were associated with the risk of uncontrolled asthma. No significant changes in PROs were observed. Conclusion: The frequency of uncontrolled asthma in the study population was high, as per JGL and GINA guidelines, despite good adherence to ICS/LABA treatment and other prescribed treatments over 12 weeks.

Does Ending a Posterior Construct Proximally at C2 Versus C3 Impact Patient Reported Outcomes in Degenerative Cervical Myelopathy Patients up to 24months After the Surgery?

Retrospective cohort study. The primary objective was to evaluate the impact of the upper instrumented level (UIV) being at C2 vs C3 in posterior cervical construct on patient reported outcomes (PROs) up to 24months after surgery for cervical degenerative myelopathy (DCM). Secondary objectives were to compare operative time, intra-operative blood loss (IOBL), length of stay (LOS), adverse events (AEs) and re-operation. Patients who underwent a posterior cervical instrumented fusion (3 and + levels) with a C2 or C3 UIV, with 24months follow-up were analyzed. PROs (NDI, EQ5D, SF-12 PCS/MCS, NRS arm/neck pain) were compared using ANCOVA. Operative duration, IOBL, AEs, and re-operation were compared. Subgroup analysis was performed on patient presenting with pre-operative malalignment (cervical sagittal vertical axis ≥40mm and/or T1slope- cervical lordosis >15°). 173 patients were included, of which 41 (24%) had a C2 UIV and 132 (76%) a C3 UIV. There was no statistically significant difference between the groups for the changes in PROs up to 24months. Subgroup analysis of patients with pre-operative malalignment showed a trend towards greater improvement in the NDI at 12months with a C2 UIV (P = .054). Operative time, IOBL and peri-operative AEs were more in C2 group (P < .05). There was no significant difference in LOS and re-operation (P > .05). In this observational study, up to 24months after surgery for posterior cervical fusion in DCM greater than 3 levels, PROs appear to evolve similarly.

Quality of Life, Physical Functioning, and Psychological Distress of Older Adults Undergoing Hematopoietic Stem Cell Transplantation

With advances in therapies for hematologic cancers, older adults increasingly undergo hematopoietic stem cell transplantation (HSCT). Older adults may potentially experience an exaggerated burden of toxicity from HSCT. Studies examining the quality of life (QOL), physical functioning, and psychological symptom trajectory for older adults undergoing HSCT are limited. Our primary aim was to describe the trajectory of QOL, physical functioning, and psychological distress of older adults undergoing HSCT. Secondarily, we aimed to compare the trajectory of QOL, physical functioning, and psychological distress of older and younger adults undergoing HSCT and to evaluate factors associated with QOL trajectory in older adults undergoing HSCT. We conducted secondary analyses of two prospective studies conducted at Massachusetts General Hospital. From 2011 to 2016, we enrolled 250 adults undergoing allogeneic or autologous HSCT. Older age was defined as age ≥65 years. We collected patient-reported outcomes (PROs) within 72 hours of admission for HSCT, at hematologic nadir (2 weeks), and at 6 months after HSCT. To assess QOL, physical functioning, and psychological symptoms, we used the Functional Assessment of Cancer Therapy (FACT)–Bone Marrow Transplant, FACT-Trial Outcome Index, and Patient Health Questionnaire–9, respectively. We used the post-traumatic stress disorder (PTSD) Checklist–Civilian Version to assess PTSD symptoms. We fit linear mixed effects models to characterize trajectories of changes in PROs across timepoints and to evaluate baseline factors associated with QOL trajectories in older adults. Overall 30.4% (76/250) of our cohort was 65 years or older. All older adults undergoing allogeneic HSCT received a reduced intensity conditioning regimen. At 2 weeks after HSCT, older patients experienced a decline in QOL (Δ = −16.6, P < .001), physical functioning (Δ = −15.4, P < .001) and an increase in depression symptoms (Δ = 3.8, P < .001). At 6 months after HSCT, QOL (Δ = 1.4, P = .7), physical functioning (Δ = 1.7, P = .5), and depression symptoms (Δ = 0.4, P = .6) recovered to baseline values. At 6 months after HSCT, the proportion of older patients with PTSD symptoms increased from 5.3% (4/76) at baseline to 13.2% (10/76). There was no significant difference in slopes or trajectories of PROs between older and younger patients. In older adults, baseline psychological distress was associated with significantly worse QOL trajectory (Δ= −21.6, P ≤ .001). Older adults experienced a sharp decline in QOL and physical functioning and an increase in depression symptoms within 2 weeks of HSCT hospitalization. Baseline psychological distress was associated with a pronounced worsening in post-HSCT QOL trajectory. These findings underscore the need for supportive care interventions to improve the experience of older adults undergoing HSCT.

Quality of total hip arthroplasty health care based on four years of patient-reported outcomes in the Netherlands

BackgroundJoint arthroplasty registries have incorporated patient-reported outcomes (PROs) to evaluate outcomes from a patients’ perspective to improve total hip arthroplasty (THA). To draw valid conclusions on PROs, a minimum response rate (RR) of 60% is advised. This study investigated (1) if the quality of THA health care based on PROs improved over the years in the Netherlands, (2) if RRs improved over the years, and (3) difference in PROs over the years in hospitals with RR ≥ 60% compared to RR < 60%.MethodsLongitudinal study with publicly available datasets from 2016 to 2019. Primary outcome was increase/decrease in PRO change scores including 95%CI ranges over the years between preoperatively and 3 months postoperatively (pre-3 m), and 12 months postoperatively (pre-12 m). Improved quality of health care was arbitrary defined as when ≥ 3 of 4 included scores or ranges were statistically significant improved. Secondary outcome was increase/decrease in RRs over the years. Subgroups RR ≥ 60% and RR < 60% were compared.ResultsHospitals (%) collecting THA PROs increased from 78 to 92%. EQ VAS change score increased over the years, and 95%CI ranges of EQ VAS, EQ-5D descriptive system and NRS pain during activity decreased over the years at pre-3 m (p < 0.05). All THA pre-12 m PRO change scores and 95%CI ranges remained equal (p > 0.05). Pre-3 m RR remained equal (around 43%, p = 0.107) and pre-12 m RR decreased 9% (49% to 40%, p = 0.008). Pre-3 m subgroup RR ≥ 60% was too small to analyse (5%). No difference was found between pre-12 m subgroups (RR ≥ 60% = 16%), p > 0.05).ConclusionsQuality of THA health care based on PROs seems equal in the Netherlands between 2016 and 2019. Although more hospitals participated in PRO collection, low RRs with large IQRs are observed and only 16% of the hospitals achieved the advised RR ≥ 60%. Multiple recommendations are provided to improve PRO collection and use.

Accelerometer-Based Navigation in Primary Total Knee Arthroplasty Leads to Improved Alignment but No Change in Patient-Reported Outcomes

BackgroundComputer and accelerometer-based navigation (ABN) tools have demonstrated improved mechanical alignment in primary total knee arthroplasty (TKA). ABN, in particular, is attractive due to avoidance of pins and trackers. Prior literature has yet to demonstrate an associated improvement in functional outcomes using ABN compared to conventional instrumentation (CONV). The purpose of this study was to compare alignment and functional outcomes between CONV and ABN in primary TKA in a large patient series. MethodsA retrospective study of 1,925 TKAs performed by a single surgeon sequentially was performed. There were 1,223 TKAs performed with CONV and measured resection technique. There were 702 TKAs performed with distal femoral ABN and restricted kinematic alignment goals. We compared radiographic alignment, Patient-Reported Outcomes Measurement Information System scores, rates of manipulation under anesthesia, and needs for aseptic revisions between cohorts. Chi-squared, Fisher’s exact, and t-tests were used to compare demographics and outcomes. ResultsThe ABN cohort had higher rates of neutral alignment postoperatively than the CONV cohort (ABN 74% versus CONV 56%, P < .001). Rates of manipulation under anesthesia (ABN 2.8% versus CONV 3.4%, P = .382) and aseptic revision (ABN 0.9% versus CONV 1.6%, P = .189) were similar. The Patient-Reported Outcomes Measurement Information System physical function (ABN 42.6 versus CONV 42.9, P = .4554), physical health (ABN 63.4 versus CONV 63.3, P = .944), mental health (ABN 51.4 versus CONV 52.7, P = .4349), and pain (ABN 32.7 versus CONV 30.9, P = .256) scores were similar. ConclusionABN is valuable in its ability to improve postoperative alignment but does not improve complication rates or patient-reported functional outcomes.

Feasibility and first results of the ‘Trials-within-Cohorts’ (TwiCs) design in patients undergoing radiotherapy for lung cancer

Background: ‘Trials-within-Cohorts’ (TwiCs), previously known as ‘cohort multiple randomized controlled trials’ is a pragmatic trial design, supporting an efficient and representative recruitment of patients for (future) trials. To our knowledge, the ‘COhort for Lung cancer Outcome Reporting and trial inclusion’ (COLOR) is the first TwiCs in lung cancer patients. In this study we aimed to assess the feasibility and first year results of COLOR.Material and Methods: All patients diagnosed with lung cancer referred to the Radiotherapy department were eligible to participate in the ongoing prospective COLOR study. At inclusion, written informed consent was requested for use of patient data, participation in patient-reported outcomes (PROs), and willingness to participate in (future) trials. Feasibility was studied by assessing participation and comparing baseline PROs to EORTC reference values. First-year results of PROs at baseline and 3 months after inclusion were evaluated separately for stereotactic body radiotherapy (SBRT) and conventional radiotherapy patients.Results: Of the 338 eligible patients between July 2020 and July 2021, 169 (50%) participated. Among these, 127 (75%) gave informed consent to PROs participation and 110 (65%) were willing to participate in (future) trials. The inclusion percentage dropped from 77% to 33% when the information procedure was switched from in-person to by phone (due to COVID-19 pandemic measures). Baseline PROs for physical and cognitive functioning were comparable in COLOR patients compared to the EORTC reference values. No significant changes in PROs were observed 3 months after inclusion, except for a slight increase in pain scores in the SBRT group (n = 97).Conclusions: The TwiCs-design appears feasible in lung cancer patients with fair participation rates (although negatively impacted by the COVID-19 pandemic). With a planned expansion to other centers, the COLOR-study is expected to enable multiple (randomized) evaluations of experimental interventions with important advantages for recruitment, generalizability, and long-term outcome data collection.

Rationale and study design of the GOREISAN for heart failure (GOREISAN-HF) trial: A randomized clinical trial

BackgroundThe decongestion strategy using loop diuretics is essential for improving signs and symptoms of heart failure (HF). However, chronic use of loop diuretics in HF has been linked to worsening renal function and adverse clinical outcomes in a dose-dependent manner. Goreisan, a traditional Japanese herbal medicine, has a long history of use in Japan for regulating body fluid homeostasis and has been recognized as causing less adverse outcomes such as dehydration in contrast to loop diuretics in clinical practice. Therefore, we designed the GOREISAN-HF trial to evaluate the long-term effects of a new decongestion strategy adding Goreisan to usual care in patients with HF and volume overload. MethodsThe GOREISAN-HF trial is an investigator-initiated, multicenter, pragmatic, randomized, comparative effectiveness trial in which we will enroll 2,192 patients hospitalized for HF at 68 hospitals in Japan. All study participants will be randomly assigned to either a decongestion strategy that adds Goreisan at a dose of 7.5 g daily on top of usual care or usual care alone. Investigators have the flexibility to change the existing diuretic regimen in both groups. The primary end point is the improvement rate of cardiac edema at 12-month follow-up, and the co-primary end point is a composite of all-cause death or hospitalization up to the end of the planned follow-up period. Secondary end points include longitudinal changes in patient-reported outcomes, loop diuretics dose, and renal function. ConclusionsThe GOREISAN-HF is the first large-scale randomized pragmatic trial to assess the efficacy and safety of a new congestion control strategy adding Goreisan to usual care in patients with HF and volume overload. Registration Number: NCT04691700

Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study.

To assess changes in the Patient-Reported Outcomes Measurement Information System (PROMIS®) outcomes related to social, mental, and physical well-being after approximately 1year of intravenous (IV) golimumab or infliximab treatment in patients with rheumatoid arthritis (RA) using real-world evidence from AWARE. AWARE was a prospective, noninterventional, multicenter, observational, U.S.-based phase 4 study of 1270 RA patients who initiated treatment with IV golimumab or infliximab. PROMIS-29 and PROMIS short form (SF) Fatigue 7a and Pain Interference 6b questionnaires were administered at baseline and infusions 2, 5, and 8 (approximately weeks 4, 28, and 52 for IV golimumab and weeks 2, 22, and 46 for infliximab). Mean changes from baseline in all PROMIS-29 domains and respective SFs and response rates for achieving ≥ 3, ≥ 5, or ≥ 10-point improvements were determined. Among all patients, baseline mean ± SD PROMIS T-scores were consistent between treatment groups and indicated worse physical function (38.2 ± 6.8 IV golimumab, 38.0 ± 6.9 infliximab), more pain interference (63.0 ± 7.6 IV golimumab, 63.9 ± 7.8 infliximab), and greater fatigue (58.4 ± 9.9 IV golimumab, 59.4 ± 10.0 infliximab) in these patients vs the general U.S. population (T-score = 50). Through the 8th infusion of either treatment, IV golimumab- and infliximab-treated patients achieved meaningful improvements (≥ 3-point improvement in T-scores) in all PROMIS-29 domains and respective SFs, and the proportions of patients with ≥ 3, ≥ 5, or ≥ 10-point improvements in T-scores increased from infusion 2 through infusion 8. RA patients treated with IV golimumab or infliximab achieved comparable improvements across social, mental, and physical well-being PROMIS measures. Additionally, PROMIS detected meaningful clinical changes in patient-reported outcomes in both treatment groups. NCT02728934.

Initial results of a phase 2 pilot study of radium-223 and radiotherapy in untreated hormone-naïve men with oligometastatic prostate cancer to bone.

156 Background: We hypothesized that treatment with Radium-223 (Ra223) and to ≤5 sites of bony metastases (mets) could safely delay the time to start androgen deprivation therapy (ADT) and maintain quality of life (QoL). Methods: 20 men previously treated with surgery, radiation, or both for M0 PCa later developed ≤5 bone-only mets were eligible for this prospective trial. Inclusion: testosterone ≥ 100 ng/dL and mets on conventional bone scan, validated by a CT, MRI, or PET/CT. Exclusion: LHRH therapies after initial treatment, or N1 disease at diagnosis of bone mets. Therapy was 6 cycles of Ra223 and SBRT (30 Gy in 5 fractions between cycles 1-2). Bone scan was performed at baseline and q3 months. PSA was evaluated monthly during the Ra223 course, and q3 months after. Therapeutic effectiveness was defined as ≥20% of patients meeting the primary endpoint of freedom from ADT (FFAdt) use at 15 months. Discontinuation of study therapy occurred if: PSA rise &gt; 10% if baseline PSA &gt;20ng/ml, PSA&gt;20 if baseline PSA &lt;20 ng/ml, radiographic progression or a skeletal-related event (SRE). All endpoints were timed from the Cycle 1 radium date. Patients were followed for 2 years. Clinically significant changes in patient-reported outcome (PRO) measures were defined as &gt;1/2 standard deviation from the mean baseline value and were censored after the time of ADT use. Continuous and categorical covariates were compared using the Wilcoxon rank sum and Pearson’s Chi2 tests, respectively, and univariate Cox regression. Statistical significance was considered at P&lt;0.05. Results: The median number of Ra223 cycles was 6. 6 patients had &lt;6 cycles (range 2-5) due to progression. FFAdt at 15 and 24 Months was 49.5% and 38.5%, respectively (p&lt;0.001). The median time to ADT was 14.8 months. There were no significant changes from baseline in any PRO QoL domain (physical functioning, anxiety, depression, fatigue, satisfaction with participation in social roles, sleep disturbance, and pain interference). There were 2 patients with Grade 3 SREs (bone fracture, pain). Grade 2+ events attributed as possible or likely to Ra-223 were seen in 4 patients (bone pain, fatigue, fracture, decreased WBC count, and other). Grade 2+ events attributed as possible or likely to EBRT were seen in 2 patients and included fatigue and other pain. were noted for age, baseline PSA, days from primary treatment, NCCN risk group, TNM stage, ISUP grade group, BMI, or # of lesions in those who met or failed the primary endpoint (all p&gt;0.05). Conclusions: First-line use of Ra223 and SBRT to oligomets in hormone-naïve men in this prospective pilot study resulted in a significant delay in ADT use compared to historical control, is well tolerated, and maintains QoL. Clinical trial information: NCT03304418 .

Clinical Outcomes After Viewing Video Education on Danger Signs and Symptoms of Worsening Heart Failure and Self-care Actions

Background Patients with heart failure (HF) must understand subtle escalation in fatigue, dyspnea, and edema before they are triggered to control worsening status. Objective The aim of this paper is to examine if video education of HF danger signs or symptoms recognition and control, developed using symbolic modeling (social cognitive theory), leads to between-group differences in functional status, symptoms, and self-efficacy for managing symptoms at 30-days, all-cause, and HF-related hospitalization, emergency department visits, and death at 30, 90, and 180 days. Methods Using a 2-group, randomized controlled, multicenter, single-blind design, patients received video education (VE) plus usual care (UC) or UC alone before hospital discharge. VE patients also had access to content post discharge. Thirty-day functional status, fatigue, dyspnea, and self-efficacy for managing symptoms were assessed using valid, reliable tools. In the analysis, multivariable models were created to compare changes in patient-reported outcomes from baseline to 30-days post discharge and morbidity or mortality outcomes up to 180 days. Results Of 369 VE and 377 UC patients enrolled from 7 sites, mean age was 68.0 (SD 12.4) years, and 206 (55.9%) were male. At 30 days, there were no between-group differences in the change in functional status, fatigue, dyspnea, and self-efficacy from baseline. In multivariable analyses, between-group outcomes did not differ at 30 or 90 days. At 180 days, HF-related events and HF-related hospitalization were higher in the video group—odds ratios (95% CI): 1.42 (1.04, 1.94), P=.03; and 1.44 (1.05, 1.97), P=.03, respectively. In time-to-event adjusted analyses, video patients had earlier HF-related hospitalization, compared to UC patients—hazard ratio (95% CI) 1.32 (1.02, 1.72), P=.04. Conclusions Video education on recognition and control of danger signs or symptoms paradoxically increased HF-related events and hospitalization and decreased time to first HF-related hospitalization. Increased recognition of subtle HF signs or symptoms via video education is valuable but must be connected to patient or family self-care actions that reduce HF signs or symptoms. Trial Registration ClinicalTrials.gov NCT03657459; https://clinicaltrials.gov/ct2/show/NCT03657459 Conflicts of Interest None declared.

Impact of early age at menopause on disease outcomes in postmenopausal women with rheumatoid arthritis: a large observational cohort study of Korean patients with rheumatoid arthritis

ObjectivesTo assess the differences in clinical outcomes between patients with rheumatoid arthritis (RA) with early menopause (EM) (<45 years) and usual menopause (UM) (≥45 years) and to identify the impact...

Patient-Reported Outcomes Among Patients Ages Two to Seventeen Years With Polyarticular-Course Juvenile Idiopathic Arthritis Treated With Subcutaneous Abatacept: Two-Year Results From an International Phase III Study.

To describe longitudinal changes in patient-reported outcomes (PROs) in children with polyarticular-course juvenile idiopathic arthritis (pJIA) treated with subcutaneous abatacept. Secondary analysis of a single-arm, open-label 24-month study of patients ages 6-17 years and 2-5 years. PROs included Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), parent global assessment of child well-being (PaGA), pain assessment, and Activity Limitation Questionnaire (ALQ). Clinical outcomes included 50% or greater improvement in JIA American College of Rheumatology (ACR) criteria, clinically inactive disease, and Juvenile Arthritis Disease Activity Score. For the 6- to 17-year-old (n=173) and 2- to 5-year-old (n=46) cohorts, respectively, median (Q1, Q3) changes from baseline in CHAQ-DI at months 4 and 24 were -0.3 (-0.8, 0.0) and -0.5 (-1.0, -0.1), and -0.4 (-0.8, 0.0) and -0.5 (-1.0--0.1). Median pain scores were below cutoff threshold for clinically relevant pain (<35 mm) by month 1 (6 to 17 years, 32.3 mm; 2 to 5 years, 25.7 mm), reaching a nadir at month 24 (6 to 17 years, 6.0 mm; 2 to 5 years, 2.0 mm). For the 6- to 17-year-old and 2- to 5-year-old cohorts, respectively, median PaGA scores were 47.8 (n=172) and 42.1 (n=46) at baseline and 6.3 (n=107) and 2.0 (n=37) at month 24. In both cohorts, ALQ components improved from baseline to month 4 and were largely maintained to month 24. Clinical outcomes improved through to month 24. Early and sustained PRO improvements were reported in this phase III, open-label trial of subcutaneous abatacept in patients with pJIA.

Patient Perspectives on the Use of Digital Technology to Help Manage Cystic Fibrosis.

Digital health technologies (DHTs) have shown potential to improve health outcomes through improved medication adherence in different disease states. Cystic fibrosis (CF) requires care coordination across pharmacies, patients, and providers. DHTs can potentially support patients, providers, and pharmacists in diseases like CF, where high medication burden can negatively impact patient quality of life and outcomes. In this prospective cohort study, a CF-specific mobile application (Phlo) was distributed to adults with CF who received care at the University of Utah Cystic Fibrosis Center, used an iPhone, and filled prescriptions through the University of Utah Specialty Pharmacy services. Participants were asked to use Phlo for 90 days with an optional 90-day extension period. Participants completed four surveys at baseline and after 90 days. Changes in patient-reported outcomes, adherence, clinical outcomes, and healthcare resource utilization from baseline to 90 days were tracked. Phlo allowed users to track daily regimen activities, contact their care team, receive medication delivery reminders, and share progress with their healthcare team. A web-based dashboard allowed the care team to review reported performance scores from the app. Most patients (67%) said the app improved confidence in and motivation for continuing their regimen. The most important reported benefit of Phlo was having a single location to manage their whole routine. Phlo is a mobile health technology designed to help patients with CF manage their treatment regimen and improve patient-provider communication.

Improvements in health status with revefenacin, a once-daily, nebulized, long-acting muscarinic antagonist for chronic obstructive pulmonary disease

BackgroundReplicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 μg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men. MethodsParticipants were pooled from the two 12-week studies (411 [51%] women and 401 [49%] men). Changes in PROs were assessed overall and separately in men and women. ResultsRevefenacin improved SGRQ and CAT total scores from baseline in both studies; improvement in CCQ total score reached significance only in 0126. In pooled data, a greater proportion of patients achieved clinically meaningful response in SGRQ score (≥4-unit decrease from baseline) with revefenacin vs placebo (odds ratio, 1.5; 95% confidence interval, 1.1–2.1; P = 0.012). Clinically meaningful responses were also seen in CAT (≥2-unit decrease from baseline) and CCQ (≥0.4-unit decrease from baseline) scores with revefenacin vs placebo. When stratified by sex, improvements from baseline in SGRQ, CAT, and CCQ scores following revefenacin vs placebo reached statistical significance only in women. ConclusionsMaintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men. Clinicaltrials.govNCT02459080; NCT02512510.

Patient-Reported Outcomes During and After Hepatitis C Virus Direct-Acting Antiviral Treatment Among People Who Inject Drugs

ObjectivesPeople who inject drugs (PWID) are at a high risk of hepatitis C virus (HCV) infection. HCV cure is associated with improved patient-reported outcomes (PROs), but there are little data among PWID. This study aimed to assess the change in PROs during and after HCV direct-acting antiviral (DAA) treatment. MethodsThis analysis used data from 2 clinical trials of DAA treatment in PWID. PROs assessed included health-related quality of life, social functioning, psychological distress, housing, and employment. Generalized estimating equations and group-based trajectory modeling were used to assess changes in PROs over time. ResultsNo significant changes in the 3-level version of EQ-5D scores, EQ visual analogue scale scores, social functioning, psychological distress, and housing were observed over the 108-week study period. There was a significant increase in the proportion of participants employed (18% [95% confidence interval (CI) 12%-23%] at baseline to 28% [95% CI 19%-36%] at the end of the study). Participants were more likely to be employed at 24 weeks and 108 weeks after commencing treatment. Having stable housing increased the odds of being employed (odds ratio 1.70; 95% CI 1.00-2.90). The group-based trajectory modeling demonstrated that most outcomes remained stable during and after DAA treatment. ConclusionsAlthough no significant improvement was identified in health-related quality of life after HCV DAA treatment, there was a modest but significant increase in employment during study follow-up. The study findings support the need for multifaceted models of HCV care for PWID addressing a range of issues beyond HCV treatment to improve quality of life.

Quality of Survival, Not Just Quantity of Time

Recovery of Patient-Reported Quality of Life After EsophagectomyThe Annals of Thoracic SurgeryPreviewEsophagectomy is an important, but potentially morbid, operation used to treat benign and malignant conditions that may significantly impact patient quality of life(QOL). Patient-reported outcomes(PRO) are measures of QOL that come directly from patient self-report. This study characterizes patterns of change and recovery in PRO in the first year after esophagectomy. Full-Text PDF